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Chlorhexidine gluconate
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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)
- 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.)
- Sky Oral Rinse (by Mckesson)
- View full label-group details →
- Dosage form
- Solution
- Route
- Dental
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2021
- Label revision date
- January 2, 2024
- 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)
- 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.)
- Sky Oral Rinse (by Mckesson)
- View full label-group details →
- Dosage form
- Solution
- Route
- Dental
- 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 2021
- Label revision date
- January 2, 2024
- Manufacturer
- Bajaj Medical, LLC
- Registration number
- ANDA075561
- NDC root
- 61037-469
- 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 0.12% Oral Rinse is a mouthwash that contains 0.12% chlorhexidine gluconate, a compound that helps manage oral health. It is primarily used between dental visits to treat gingivitis, which is an inflammation of the gums that can cause redness, swelling, and bleeding. This rinse works by releasing chlorhexidine gluconate into your mouth, where it can help reduce bacteria and promote healthier gums.
When you use this oral rinse, about 30% of the chlorhexidine gluconate stays in your mouth, allowing it to work effectively over time. It is important to note that this product is not absorbed well by the body and is mostly eliminated through feces. Chlorhexidine gluconate is a valuable tool in maintaining oral hygiene, especially for those dealing with gingivitis.
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 this 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 rinsing. Do not rinse your mouth with water or any other mouthwash, brush your teeth, or eat right after using the rinse. Remember, this oral 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 this product. 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 oral rinse.
Side Effects
You may experience some common side effects when using chlorhexidine gluconate oral rinse, such as increased staining of your teeth and other oral surfaces, more calculus (tartar) buildup, and changes in how things taste. In rare cases (less than 1%), you might also notice oral issues like mouth ulcers, gingivitis (gum inflammation), or a coated tongue.
It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, life-threatening allergic response), have been reported. Additionally, some people have experienced dry mouth, swelling of the salivary glands, or irritation in the mouth. If you notice any unusual symptoms, it's best to consult 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. Additionally, 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 are recommended 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 this product. 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. If you notice any unusual symptoms or have concerns 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. Always err on the side of caution when it comes to your child's health.
Pregnancy Use
Reproduction studies in animals, such as rats and rabbits, have shown no evidence of harm to the fetus when given chlorhexidine gluconate at certain doses. 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
It is currently unclear whether chlorhexidine gluconate oral rinse passes into human breast milk. Since many medications can be found in breast milk, it's important to be cautious if you are a nursing mother considering this rinse.
Studies in rats during childbirth and breastfeeding showed no harmful effects on the mothers or their nursing pups, even at doses much higher than what a human would typically use. However, due to the uncertainty regarding its effects on human milk, you should consult your healthcare provider before using this product while breastfeeding.
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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.
Hepatic Impairment
If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.
Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to be aware that some dental products containing chlorhexidine can cause serious allergic reactions, including anaphylaxis, in certain individuals. If you have a history of allergies or are taking other medications, it's crucial to discuss this with your healthcare provider to ensure your safety.
Additionally, there are no specific interactions noted with other drugs or laboratory tests, but it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This helps them provide the best care tailored to your needs.
Storage and Handling
To ensure the safety and effectiveness of your chlorhexidine gluconate oral rinse, store it 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). This product comes in various sizes, including a 1-pint (473 ml) amber plastic bottle, a 4-ounce (118 ml) amber plastic bottle, a 64-ounce (1893 ml) white plastic bottle, and a 15 ml unit-dose cup, all designed with child-resistant closures for added safety.
When handling the oral rinse, make sure to keep it in a clean and safe environment. Always ensure the cap is securely closed after use to prevent spills and keep it out of reach of children. If you need to dispose of any unused product, follow local guidelines for safe disposal to protect the environment.
Additional Information
No further information is available.
FAQ
What is Chlorhexidine Gluconate 0.12% Oral Rinse used for?
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 gums, including gingival bleeding upon probing.
How should I use Chlorhexidine Gluconate oral rinse?
You should use 15 ml of undiluted chlorhexidine gluconate oral rinse twice daily for 30 seconds, morning and evening after tooth brushing. Do not rinse with water, use other mouthwashes, brush teeth, or eat immediately after rinsing.
What are the common side effects of Chlorhexidine Gluconate oral rinse?
Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and an alteration in taste perception.
Are there any warnings associated with Chlorhexidine Gluconate oral rinse?
Yes, anaphylaxis and serious allergic reactions have been reported during postmarketing use with dental products containing chlorhexidine.
Can I use Chlorhexidine Gluconate oral rinse if I am pregnant?
Chlorhexidine gluconate should be used during pregnancy only if clearly needed, as adequate and well-controlled studies in pregnant women have not been done.
Is Chlorhexidine Gluconate oral rinse safe for nursing mothers?
It is not known whether chlorhexidine gluconate is excreted in human milk, so caution should be exercised when administering it to nursing women.
What should I do if I experience an alteration in taste perception?
Some patients may experience an alteration in taste perception while using chlorhexidine gluconate oral rinse, and rare instances of permanent taste alteration have been reported.
How should Chlorhexidine Gluconate oral rinse be stored?
Store chlorhexidine gluconate oral rinse at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).
Who should not use Chlorhexidine Gluconate oral rinse?
Chlorhexidine gluconate oral rinse should not be used by individuals known to be hypersensitive to chlorhexidine gluconate or other ingredients in the formula.
Packaging Info
The table below lists all NDC Code configurations of Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution | 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
| ||||
| Solution | 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
| ||||
| Solution | 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
| ||||
| Solution | 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 Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, 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 1,1'-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 derived from 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 further guidance.
No teratogenic or nonteratogenic effects have been reported.
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, administered twice daily. Patients should perform oral rinsing for 30 seconds in the morning and evening, ideally after tooth brushing.
It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the chlorhexidine gluconate oral rinse. The solution is not intended for ingestion and must be expectorated following the rinsing procedure to ensure safety and efficacy.
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 severe allergic reactions.
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 occurrence 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, and an alteration in taste perception.
In clinical trials, several oral mucosal side effects were reported among participants, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these events occurred at a frequency of less than 1%.
Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, paresthesia, minor irritation and 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. Furthermore, some patients may experience a temporary alteration in taste perception, with rare instances of permanent taste alteration noted in post-marketing product surveillance.
Drug Interactions
Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences associated with dental products containing chlorhexidine. Healthcare professionals should remain vigilant for signs of hypersensitivity in patients using these products.
Currently, there are no specific drug or laboratory test interactions identified in the available data. Therefore, routine monitoring for drug interactions or laboratory test interference is not indicated at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution | 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
| ||||
| Solution | 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
| ||||
| Solution | 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
| ||||
| Solution | 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. Healthcare professionals should exercise caution when considering this treatment for children and adolescents, as the lack of data limits the ability to assess potential risks and benefits.
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 decisions. Monitoring for any potential 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, this drug 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 medication in pregnant patients.
Lactation
It is not known whether this drug is excreted in human milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering chlorhexidine gluconate oral rinse to nursing women.
In studies involving parturition and lactation with 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
There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
Ingestion of chlorhexidine gluconate oral rinse, particularly 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 the symptoms presented.
Nonclinical Toxicology
In a drinking water study conducted in rats, no carcinogenic effects were observed at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies involving chlorhexidine gluconate. The highest doses administered in these studies included 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. Furthermore, there was no evidence of impaired fertility in rats at doses up to 100 mg/kg/day. No information is available regarding teratogenic effects or additional animal pharmacology and toxicology data.
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. Additionally, rare cases of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing surveillance.
Among the most frequently reported oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulceration, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been observed in patients using this rinse. Furthermore, instances of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have been reported in association with the use of chlorhexidine gluconate oral rinse.
Patient Counseling
Advise patients that chlorhexidine gluconate oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling while helping to control gum bleeding. Patients should be instructed to use the oral rinse regularly, as directed by their dentist, and to continue their daily brushing routine.
Instruct patients to spit out the rinse after use, emphasizing that chlorhexidine gluconate oral rinse should not be swallowed. It is crucial to inform patients that they should seek immediate medical attention if they experience any allergic symptoms, such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. Additionally, patients should be made aware that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components.
Patients should be informed that the use of chlorhexidine gluconate oral rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. It is important for patients to see their dentist for the removal of any stain or tartar at least every six months, or more frequently if advised by their dentist. Both stain and tartar can be effectively removed by a dentist or hygienist.
Patients should also be cautioned that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration.
Inform patients that the rinse may have a bitter taste and can alter the taste of food and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, patients should be advised to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.
Encourage patients to reach out to their dentist, pharmacist, or Bajaj Medical at 1-800-581-2528 if they have any questions or comments regarding chlorhexidine gluconate oral rinse. Additionally, patients should be advised to contact their healthcare provider for medical advice about any side effects and to report side effects to the FDA at 1-800-FDA-1088.
Storage and Handling
Chlorhexidine gluconate oral rinse is supplied in the following configurations: a 1-pint (473 ml) amber plastic bottle with a child-resistant dispensing closure, a 4-ounce (118 ml) amber plastic bottle with a child-resistant closure, a 64-ounce (1893 ml) white plastic bottle with a foam-lined closure, and a 15 ml unit-dose cup.
Storage conditions require that the product be maintained at a temperature 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. Proper handling and storage are essential to ensure the integrity and efficacy of the product.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Chlorhexidine Gluconate, 0.12% Oral Rinse Solution as submitted by Bajaj Medical, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.