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Sky Oral Rinse
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- Active ingredient
- Chlorhexidine Gluconate 1.2 mg/1 mL
- Other brand names
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Betasept (by Xttrium Laboratories, Inc.)
- Chlorhexidine (by Pinnacle Pharma Llc)
- Chlorhexidine Gluconate (by Atlantic Biologicals Corp.)
- Chlorhexidine Gluconate (by Atlantic Biologicals Corps.)
- Chlorhexidine Gluconate (by Benco Dental)
- Chlorhexidine Gluconate (by Darby Dental Supply, Llc)
- Chlorhexidine Gluconate (by Den-Mat Holdings, Llc)
- Chlorhexidine Gluconate (by Lohxa)
- Chlorhexidine Gluconate (by Lyne Laboratories, Inc.)
- Chlorhexidine Gluconate (by Medline Industries, Lp)
- Chlorhexidine Gluconate (by Pai Holdings, Llc Dba Pai Pharma)
- Chlorhexidine Gluconate (by Remedyrepack Inc.)
- Chlorhexidine Gluconate (by Vistapharm, Llc)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Chartwell Governmental & Specialty Rx, Llc.)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Chartwell Rx, Llc)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Sage Products Llc)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate Oral Rinse (by Brisk Pharmaceuticals)
- Chlorhexidine Gluconate Oral Rinse (by Rising Pharma Holdings, Inc.)
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (by A2a Integrated Pharmaceuticals, Llc)
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (by Bajaj Medical, Llc)
- Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse (by Safco Dental Supply Llc)
- Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse (by Safco Dental Supply Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Cardinal Health 107, Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Cardinal Health 107, Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Natco Pharma Usa Llc)
- Denti-Care Denti-Rinse (by Xttrium Laboratories, Inc.)
- Major Oral Rinse (by Cardinal Health 107, Llc)
- Major Oral Rinse (by Cardinal Health 107, Llc)
- Major Oral Rinse (by Major Pharmaceuticals)
- Nupro Chlorhexidine Gluconate (by Dentsply Llc. Professional Division Trading as "dentsply Professional")
- Nupro Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Peridex (by Solventum Us Llc)
- Periochip (by Adrian Pharmaceuticals, Llc)
- Periogard Alcohol Free (by Atlantic Biologicals Corp.)
- Periogard Alcohol Free (by Colgate Oral Pharmaceuticals, Inc.)
- Periogard Alcohol Free (by Colgate Oral Pharmaceuticals, Inc.)
- View full label-group details →
- Dosage form
- Rinse
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- September 26, 2022
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Chlorhexidine Gluconate 1.2 mg/1 mL
- Other brand names
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Henry Schein, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Betasept (by Xttrium Laboratories, Inc.)
- Chlorhexidine (by Pinnacle Pharma Llc)
- Chlorhexidine Gluconate (by Atlantic Biologicals Corp.)
- Chlorhexidine Gluconate (by Atlantic Biologicals Corps.)
- Chlorhexidine Gluconate (by Benco Dental)
- Chlorhexidine Gluconate (by Darby Dental Supply, Llc)
- Chlorhexidine Gluconate (by Den-Mat Holdings, Llc)
- Chlorhexidine Gluconate (by Lohxa)
- Chlorhexidine Gluconate (by Lyne Laboratories, Inc.)
- Chlorhexidine Gluconate (by Medline Industries, Lp)
- Chlorhexidine Gluconate (by Pai Holdings, Llc Dba Pai Pharma)
- Chlorhexidine Gluconate (by Remedyrepack Inc.)
- Chlorhexidine Gluconate (by Vistapharm, Llc)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Chartwell Governmental & Specialty Rx, Llc.)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Chartwell Rx, Llc)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Sage Products Llc)
- Chlorhexidine Gluconate 0.12% Oral Rinse (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate Oral Rinse (by Brisk Pharmaceuticals)
- Chlorhexidine Gluconate Oral Rinse (by Rising Pharma Holdings, Inc.)
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (by A2a Integrated Pharmaceuticals, Llc)
- Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (by Bajaj Medical, Llc)
- Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse (by Safco Dental Supply Llc)
- Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse (by Safco Dental Supply Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Cardinal Health 107, Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Cardinal Health 107, Llc)
- Dash Chlorhexidine Gluconate 0.12% Oral Rinse (by Natco Pharma Usa Llc)
- Denti-Care Denti-Rinse (by Xttrium Laboratories, Inc.)
- Major Oral Rinse (by Cardinal Health 107, Llc)
- Major Oral Rinse (by Cardinal Health 107, Llc)
- Major Oral Rinse (by Major Pharmaceuticals)
- Nupro Chlorhexidine Gluconate (by Dentsply Llc. Professional Division Trading as "dentsply Professional")
- Nupro Chlorhexidine Gluconate (by Xttrium Laboratories, Inc.)
- Peridex (by Solventum Us Llc)
- Periochip (by Adrian Pharmaceuticals, Llc)
- Periogard Alcohol Free (by Atlantic Biologicals Corp.)
- Periogard Alcohol Free (by Colgate Oral Pharmaceuticals, Inc.)
- Periogard Alcohol Free (by Colgate Oral Pharmaceuticals, Inc.)
- View full label-group details →
- Dosage form
- Rinse
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2020
- Label revision date
- September 26, 2022
- Manufacturer
- McKesson
- Registration number
- ANDA077789
- NDC root
- 63739-052
- FDA Insert
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Chlorhexidine gluconate oral rinse is a medicated mouthwash that contains 0.12% chlorhexidine gluconate, a compound designed to help manage oral health. It is primarily used as part of a professional dental care program to treat gingivitis, which is characterized by symptoms such as redness, swelling, and bleeding of the gums. This rinse works by being retained in the mouth after rinsing, where it is slowly released to help reduce bacteria and inflammation.
This oral rinse is not absorbed well by the body and is mostly eliminated through the feces, making it effective for localized treatment in the mouth. It is important to use this rinse as directed by your dental professional to achieve the best results in maintaining your oral health.
Uses
Chlorhexidine gluconate oral rinse is designed to help you manage gingivitis, which is an inflammation of the gums that can cause redness, swelling, and bleeding when you probe the gums. This rinse is typically used between dental visits as part of a professional treatment program to improve your gum health.
It's important to note that chlorhexidine gluconate oral rinse has not been tested for use in patients with acute necrotizing ulcerative gingivitis (ANUG), a more severe form of gum disease. If you have both gingivitis and periodontitis (another type of gum disease), you should consult your healthcare provider for specific guidance.
Dosage and Administration
After your dental cleaning, you can start using chlorhexidine gluconate oral rinse to help maintain your oral health. You should use it twice a day, in the morning and evening, for 30 seconds each time. The usual amount to use is 15 ml of the rinse, which you should not dilute.
It's important to follow a few guidelines after using the rinse. Do not rinse your mouth with water or any other mouthwash, brush your teeth, or eat right after using chlorhexidine gluconate. Remember, this rinse is not meant to be swallowed, so make sure to spit it out after rinsing. Following these steps will help you get the most benefit from your oral rinse therapy.
What to Avoid
If you are sensitive to chlorhexidine gluconate or any other ingredients in the oral rinse, you should avoid using it. Hypersensitivity means that your body may react negatively to these substances, which could lead to unwanted side effects.
It's important to prioritize your safety, so please consult with your healthcare provider if you have any concerns or questions about using this product.
Side Effects
You may experience some common side effects while using this product, such as increased staining of your teeth and other oral surfaces, changes in your sense of taste, oral irritation, and local allergy-like symptoms. Additionally, you might notice an increase in calculus (tartar) formation. In rare cases (less than 1% of users), you could experience more serious oral mucosal side effects, including ulcers, gingivitis (gum inflammation), and other conditions affecting the mouth.
It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction), have been reported. Some users have also experienced dry mouth, swelling of the salivary glands, and other minor irritations. If you notice any unusual symptoms, it's best to consult with your healthcare provider.
Warnings and Precautions
When using chlorhexidine gluconate oral rinse, it's important to be aware that its effectiveness on periodontitis (gum disease) has not been established. Some users may experience an increase in supragingival calculus (tartar above the gum line), and while it’s unclear if it affects subgingival calculus (tartar below the gum line), regular dental cleanings should be scheduled every six months to manage any buildup.
You should be cautious of potential allergic reactions, including anaphylaxis (a severe, life-threatening allergic response), which have been reported with chlorhexidine products. If you experience any signs of a serious allergic reaction, such as difficulty breathing, swelling of the face or throat, or hives, seek emergency help immediately. Additionally, if you notice any unusual symptoms or reactions while using the rinse, stop using it and contact your doctor for further guidance.
Overdose
If a small child, weighing around 10 kg, accidentally swallows 1 or 2 ounces of chlorhexidine gluconate oral rinse, they may experience stomach upset, such as nausea, or show signs similar to alcohol intoxication. It's important to monitor them closely for any unusual behavior or symptoms.
If more than 4 ounces of the rinse is ingested, or if you notice any signs of alcohol intoxication, you should seek medical attention immediately. Signs of alcohol intoxication can include confusion, difficulty walking, or unusual drowsiness. Always err on the side of caution and contact a healthcare professional if you have any concerns about an overdose.
Pregnancy Use
Reproduction studies in animals, such as rats and rabbits, have shown no evidence of harm to the fetus when given high doses of chlorhexidine gluconate. However, it's important to note that there have not been adequate and well-controlled studies in pregnant women. Since results from animal studies do not always predict how humans will respond, you should use this drug during pregnancy only if it is clearly necessary. Always consult with your healthcare provider to weigh the benefits and risks before using any medication while pregnant.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to be cautious when using chlorhexidine gluconate oral rinse, as it is not known whether this medication passes into human milk. Many medications can be found in breast milk, so it's wise to consult with your healthcare provider before using this rinse.
Studies in rats during childbirth and nursing showed no harmful effects on the mothers or their pups when given doses much higher than what a human would typically use. However, since the effects on human milk are still unclear, taking precautions is essential for your and your baby's safety. Always discuss any concerns with your doctor to ensure the best choices for you and your child.
Pediatric Use
When considering the use of chlorhexidine gluconate oral rinse for your child, it's important to note that its effectiveness and safety have not been established for children under 18 years old. This means that there is not enough evidence to confirm that it is safe or works well for younger individuals. Always consult with your child's healthcare provider before using this product to ensure it is appropriate for their specific needs.
Geriatric Use
When considering the use of chlorhexidine gluconate oral rinse, it's important to note that its effectiveness and safety have not been established for children under 18 years old. For older adults, there are no specific recommendations or dosage adjustments mentioned in the available information. This means that while the product may be used, it is essential to consult with a healthcare provider to ensure it is appropriate for your individual health needs. Always prioritize open communication with your doctor about any concerns or questions regarding treatments.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to be aware of how certain medications, like chlorhexidine gluconate oral rinse, may affect you. While the specific impact of this rinse on periodontitis (gum disease) hasn't been established, there are some considerations to keep in mind. Clinical studies have shown that using this rinse can lead to an increase in supragingival calculus (tartar above the gum line), so regular dental cleanings should be scheduled every six months to manage this.
Additionally, be cautious as there have been reports of serious allergic reactions, including anaphylaxis, associated with dental products containing chlorhexidine. If you experience any unusual symptoms after using this rinse, it's crucial to seek medical attention promptly. Always consult your healthcare provider for personalized advice and to ensure safe use of any dental products.
Drug Interactions
It's important to talk to your healthcare provider about any medications or tests you may be taking or undergoing. In the case of chlorhexidine gluconate oral rinse, there are no specific drug or laboratory test interactions noted. However, your healthcare provider can help ensure that this rinse is safe and effective for you, especially if you are using other treatments or have specific health concerns. Always keep an open line of communication with your provider to ensure the best care for your health.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it as close to the recommended range as possible.
Always keep the product out of reach of children to prevent any accidental misuse. Handling the product with care will help maintain its effectiveness and safety.
Additional Information
Chlorhexidine gluconate oral rinse should be used regularly as directed by your dentist, alongside your daily brushing routine. Be aware that it may cause some tooth discoloration and an increase in tartar buildup, especially in areas where stains typically form. To minimize these effects, brush and floss daily, focusing on areas that may start to discolor, and visit your dentist for cleanings at least every six months.
If you experience any allergic reactions, such as a skin rash, difficulty breathing, or rapid heart rate, seek medical attention immediately. This rinse may taste bitter and can alter the taste of food and drinks, but this usually improves with continued use. To reduce taste interference, consider rinsing with chlorhexidine gluconate after meals and avoid rinsing with water or other mouthwashes right after. If you have questions or concerns, reach out to your dentist or pharmacist, and report any side effects to Xttrium Laboratories or the FDA.
FAQ
What is chlorhexidine gluconate oral rinse?
Chlorhexidine gluconate oral rinse is a 0.12% solution used to treat gingivitis, characterized by redness and swelling of the gums.
How should I use chlorhexidine gluconate oral rinse?
You should rinse with 15 ml of undiluted chlorhexidine gluconate oral rinse for 30 seconds, twice daily, after brushing your teeth.
What should I avoid after using chlorhexidine gluconate oral rinse?
Do not rinse with water, use other mouthwashes, brush your teeth, or eat immediately after using the rinse.
What are the common side effects of chlorhexidine gluconate oral rinse?
Common side effects include increased staining of teeth, alteration in taste perception, oral irritation, and local allergy-type symptoms.
Can I use chlorhexidine gluconate oral rinse if I am pregnant?
Chlorhexidine gluconate oral rinse should be used during pregnancy only if clearly needed, as adequate studies in pregnant women have not been conducted.
Is chlorhexidine gluconate oral rinse safe for children?
The clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under 18 years of age.
What should I do if I experience an allergic reaction?
If you develop symptoms like skin rash, swelling, or breathing difficulties, seek medical attention immediately.
How should I store chlorhexidine gluconate oral rinse?
Store the rinse at 20°C to 25°C (68°F to 77°F), and keep it out of reach of children.
What should I do if I have questions about chlorhexidine gluconate oral rinse?
Contact your dentist or pharmacist for any questions, or call your healthcare provider for medical advice about side effects.
Packaging Info
The table below lists all NDC Code configurations of Sky Oral Rinse (chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Sky Oral Rinse, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
0.12% chlorhexidine gluconate (CHG) is an oral rinse formulated with 1,11-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The product is presented in a base that includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. This formulation results in a near neutral solution with a pH range of 5 to 7. Chlorhexidine gluconate is characterized as a salt of chlorhexidine and gluconic acid.
Uses and Indications
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis, characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.
This drug has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, healthcare professionals should refer to the PRECAUTIONS section for additional guidance.
Dosage and Administration
Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 15 ml of undiluted chlorhexidine gluconate oral rinse, to be used twice daily. Patients should perform the rinsing for 30 seconds in the morning and evening, after brushing their teeth.
It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food or beverages immediately after using the oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion; patients should expectorate the solution after rinsing.
Contraindications
Chlorhexidine gluconate oral rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Use in these patients may lead to adverse reactions due to the potential for allergic responses.
Warnings and Precautions
The effect of chlorhexidine gluconate oral rinse on periodontitis has not been established. Healthcare professionals should be aware that clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users. However, it remains unclear whether the use of this oral rinse contributes to an increase in subgingival calculus.
To mitigate the potential accumulation of calculus, it is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.
Additionally, healthcare providers should remain vigilant for the possibility of anaphylaxis and other serious allergic reactions, which have been reported during postmarketing surveillance of dental products containing chlorhexidine. Monitoring for these adverse reactions is essential to ensure patient safety.
Side Effects
Patients using chlorhexidine gluconate oral rinse may experience a range of adverse reactions. Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, alterations in taste perception, oral irritation, and local allergy-type symptoms.
In clinical trials, oral mucosal side effects were reported in less than 1% of participants and included aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.
Postmarketing reports have identified additional adverse reactions such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Other observed effects include minor irritation, superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).
Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. Patients should be aware that some may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing surveillance.
Drug Interactions
Chlorhexidine gluconate oral rinse has not been associated with any specific drug interactions. Additionally, there are no reported interactions with laboratory tests related to the use of chlorhexidine gluconate oral rinse. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.
Packaging & NDC
The table below lists all NDC Code configurations of Sky Oral Rinse (chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Rinse | 1.2 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in pediatric patients under the age of 18. Therefore, its use in this population is not recommended until further data are available to support its safety and efficacy.
Geriatric Use
Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. However, there are no specific recommendations, dosage adjustments, or safety concerns noted for elderly patients.
Healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate oral rinse in geriatric patients, as individual patient factors may influence treatment outcomes. Monitoring for any adverse effects is advisable, given the lack of established data in this population.
Pregnancy
Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human responses, chlorhexidine gluconate should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of this drug in pregnant patients.
Lactation
It is not known whether chlorhexidine gluconate is excreted in human milk. Due to the potential for many drugs to be excreted in breast milk, caution should be exercised when administering chlorhexidine gluconate oral rinse to lactating mothers.
In studies involving parturition and lactation in rats, no evidence of impaired parturition or toxic effects on suckling pups was observed when chlorhexidine gluconate was administered to dams at doses exceeding 100 times the amount that would result from a human ingesting 30 ml of chlorhexidine gluconate oral rinse per day.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.
Hepatic Impairment
Patients with hepatic impairment may require careful consideration when using chlorhexidine gluconate oral rinse. The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined in this population, and it is not known if its use results in an increase in subgingival calculus. However, clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users.
For patients with compromised liver function, it is recommended that calculus deposits be managed through dental prophylaxis at intervals not exceeding six months to mitigate potential complications. Additionally, healthcare providers should remain vigilant for the occurrence of anaphylaxis and serious allergic reactions, which have been reported during postmarketing use of dental products containing chlorhexidine. Monitoring for these adverse effects is essential in patients with hepatic impairment.
Overdosage
Ingestion of chlorhexidine gluconate oral rinse in small children can lead to significant adverse effects. Specifically, the consumption of 1 or 2 ounces by a child weighing approximately 10 kg may result in gastric distress, which can manifest as nausea. Additionally, there may be signs resembling alcohol intoxication due to the formulation of the rinse.
It is imperative that medical attention is sought if a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse. The development of symptoms indicative of alcohol intoxication further necessitates immediate medical evaluation and intervention. Healthcare professionals should be vigilant in assessing the child's condition and providing appropriate management based on the severity of symptoms observed.
Nonclinical Toxicology
No teratogenic effects were observed in the studies conducted. Additionally, there was no evidence of impaired fertility in rats at doses up to 100 mg/kg/day.
In a drinking water study involving rats, no carcinogenic effects were noted at doses up to 38 mg/kg/day. Furthermore, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies utilizing chlorhexidine gluconate. The highest doses administered in these studies included 100 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test.
Postmarketing Experience
Postmarketing experience has identified several adverse events associated with the use of dental products containing chlorhexidine. Anaphylaxis and serious allergic reactions have been reported. Among the most frequently noted oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.
Additionally, minor irritation and superficial desquamation of the oral mucosa have been observed in patients using chlorhexidine gluconate oral rinse. Reports have also included cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis). Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate oral rinse. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.
Patient Counseling
Healthcare providers should inform patients that chlorhexidine gluconate oral rinse has been prescribed to treat gingivitis, specifically to reduce gum redness and swelling, as well as to help control gum bleeding. Patients should be advised to use the oral rinse regularly, as directed by their dentist, and to continue their daily brushing routine.
It is essential to instruct patients to spit out the rinse after use, as chlorhexidine gluconate oral rinse should not be swallowed. Providers should make patients aware of the potential for allergic reactions, including symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea, and advise them to seek medical attention immediately if any of these occur.
Patients with a known sensitivity to chlorhexidine gluconate or its components should be cautioned against using this product. Additionally, they should be informed that the rinse may cause tooth discoloration or an increase in tartar formation, particularly in areas where stains and tartar typically accumulate. Regular dental visits for the removal of stains and tartar, at least every six months or more frequently if recommended by their dentist, are important for maintaining oral health.
Healthcare providers should also discuss the possibility of permanent discoloration of some front-tooth fillings due to the use of chlorhexidine gluconate oral rinse. To minimize discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration.
Patients may experience a bitter taste from the rinse, which can affect the taste of foods and beverages; however, this effect usually diminishes with continued use. To mitigate taste interference, it is advisable for patients to rinse with chlorhexidine gluconate oral rinse after meals. They should also be instructed not to rinse with water or other mouthwashes immediately after using the chlorhexidine gluconate oral rinse.
For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should be encouraged to contact their dentist or pharmacist. Providers should remind patients to call their healthcare provider for medical advice about side effects and inform them that side effects can be reported to Xttrium Laboratories at 1-800-587-3721 or to the FDA at 1-800-FDA-1088.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F) in accordance with USP controlled room temperature guidelines.
It is essential to keep the product out of reach of children to ensure safety. Proper storage conditions must be maintained to preserve the integrity and efficacy of the product.
Additional Clinical Information
Chlorhexidine gluconate oral rinse should be used regularly as directed by a dentist, in conjunction with daily brushing. Patients are advised to seek immediate medical attention if they experience allergic symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. This oral rinse is contraindicated for individuals with a known sensitivity to chlorhexidine or its components.
Clinicians should inform patients that chlorhexidine gluconate oral rinse may lead to tooth discoloration and an increase in tartar formation, particularly in areas prone to staining. Regular dental visits for the removal of stain and tartar are recommended, at least every six months or more frequently as advised by the dentist. Patients should also be aware that the rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, daily brushing and flossing are essential, particularly in areas that begin to show discoloration. The rinse may have a bitter taste that can affect the taste of foods and beverages, although this typically diminishes with continued use. To reduce taste interference, it is recommended to use the rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward. For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should contact their dentist or pharmacist, and report side effects to Xttrium Laboratories or the FDA.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Sky Oral Rinse as submitted by McKesson. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.