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Skin Antisepsis, Oral Cleansing, Nasal Antisepsis
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This product has been discontinued
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- Route
- Topical
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2012
- Label revision date
- May 29, 2019
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- Route
- Topical
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2012
- Label revision date
- May 29, 2019
- Manufacturer
- Sage Products LLC
- Registration number
- NDA021669
- NDC root
- 53462-007
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
Chlorhexidine Gluconate is an oral rinse that contains 0.12% chlorhexidine gluconate, a compound designed to help manage oral health. It is primarily used as part of a professional program to treat gingivitis, which is characterized by symptoms such as redness, swelling, and bleeding of the gums.
When you use this rinse, about 30% of the active ingredient remains in your mouth, where it is gradually released into your saliva. This helps to reduce the signs of gingivitis between dental visits. Chlorhexidine gluconate is not significantly absorbed into the body, with most of it being eliminated through the feces.
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 a specific type of gum disease called acute necrotizing ulcerative gingivitis (ANUG). If you have both gingivitis and periodontitis (another form of gum disease), you should consult your healthcare provider for specific guidance.
Dosage and Administration
After your dental cleaning, you should start using Chlorhexidine Gluconate Oral Rinse. This rinse is recommended to be used twice a day, once in the morning and once in the evening, right after you brush your teeth. For each use, measure out 15 mL of the rinse and swish it around in your mouth for 30 seconds.
It's important to remember not to rinse your mouth with water or any other mouthwash, brush your teeth, or eat anything immediately after using the rinse. Also, make sure to spit it out after rinsing, as this product is not meant to be swallowed. Following these steps will help you get the most benefit from your oral rinse.
What to Avoid
If you are sensitive to chlorhexidine gluconate or any of the other ingredients in this oral rinse, you should not use it. It's important to be cautious, as using this product could lead to an allergic reaction.
Additionally, if you accidentally swallow the rinse, seek medical assistance immediately or contact a Poison Control Center. This is crucial to ensure your safety and well-being. Always use the product as directed to avoid any potential misuse or complications.
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 clinical trials, less than 1% of participants reported oral issues like mouth ulcers, gingivitis (gum inflammation), and other minor irritations.
It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction), have been reported. Additionally, some users have experienced dry mouth, swelling of the salivary glands, and other oral discomforts. If you notice any unusual symptoms, it's best to consult with your healthcare provider.
Warnings and Precautions
Using Chlorhexidine Gluconate Oral Rinse may lead to some important considerations. First, while it can help with oral hygiene, it has not been proven effective for treating periodontitis (gum disease), and it may cause an increase in dental calculus (tartar). If you notice any unusual reactions, such as severe allergic responses like anaphylaxis, seek emergency medical help immediately. Additionally, if you accidentally swallow the rinse, contact a Poison Control Center or seek medical assistance right away.
Be aware that this rinse can cause staining on your teeth and tongue, particularly if you have a lot of plaque buildup. About 56% of users may experience some staining, and in some cases, it can be heavy. While this staining does not harm your gums or other oral tissues, it may require professional cleaning to remove. If you have dental restorations with rough surfaces, you might want to discuss this with your dentist, as staining could be more difficult to clean in those areas. Lastly, some users report changes in taste perception, which can sometimes be permanent, so keep this in mind during your treatment.
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. These signs can include confusion, dizziness, or unusual behavior.
It's important to seek medical help if a child ingests more than 4 ounces of this rinse or if they display any signs of alcohol intoxication. Always err on the side of caution and contact a healthcare professional if you have concerns about an overdose.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to be cautious with products like Chlorhexidine Gluconate Oral Rinse. This rinse should not be used if you are allergic to chlorhexidine gluconate or any of its ingredients. While the effects of this rinse on gum disease (periodontitis) during pregnancy are not fully known, there have been reports of serious allergic reactions, including anaphylaxis, associated with its use.
Additionally, be aware that Chlorhexidine Gluconate Oral Rinse can cause staining on teeth and other oral surfaces, and may lead to discoloration of dental fillings, especially those in the front teeth. If you have a premature infant or an infant under 2 months old, use this product with caution, as it may cause irritation or chemical burns. Always consult your healthcare provider before using any new oral care products during pregnancy.
Lactation Use
When using Chlorhexidine Gluconate Oral Rinse, it's important to remember that this product is not meant to be swallowed; you should spit it out after rinsing. While there hasn't been specific research on how this rinse affects breastfeeding mothers or their milk, it's unclear whether the active ingredient, chlorhexidine gluconate, passes into breast milk. Therefore, if you are nursing, you should be cautious when using this oral rinse. Always consult with your healthcare provider if you have concerns about its use while breastfeeding.
Pediatric Use
Chlorhexidine Gluconate Oral Rinse is not safe for children who are allergic to chlorhexidine gluconate or any of its ingredients. If a small child, weighing around 10 kg (about 22 pounds), accidentally swallows 1 or 2 ounces of this rinse, they may experience stomach upset or symptoms similar to alcohol intoxication. If more than 4 ounces is ingested or if any signs of alcohol intoxication appear, you should seek medical help immediately.
It's important to use this product cautiously with premature infants or those under 2 months old, as it can cause irritation or even chemical burns. Always keep this rinse out of reach of children, and if it is swallowed, contact a medical professional or Poison Control Center right away.
Geriatric Use
While there is no specific information regarding the use of Chlorhexidine Gluconate Oral Rinse in older adults, it’s important to remember that every individual is unique. If you or a loved one is considering this oral rinse, it’s always a good idea to consult with a healthcare provider. They can help determine if this product is suitable for your needs and discuss any potential concerns based on your overall health and any medications you may be taking.
Since there are no specific dosage adjustments or safety precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice.
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 be aware of how certain products, like Chlorhexidine Gluconate Oral Rinse, may affect you. While the specific impact of this rinse on conditions like 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 (the hard deposits on teeth above the gum line), so regular dental cleanings every six months are recommended to manage this.
Additionally, be cautious as there have been reports of serious allergic reactions, including anaphylaxis, associated with chlorhexidine-containing dental products. If you experience any unusual symptoms after using this rinse, it's crucial to seek medical attention promptly. Always consult with your healthcare provider about the best oral care practices for your specific health needs.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are using, including Chlorhexidine Gluconate Oral Rinse. If you are allergic to chlorhexidine gluconate or any of its ingredients, you should avoid this rinse, as serious allergic reactions, including anaphylaxis, have been reported.
Additionally, while using this rinse, you may notice staining on your teeth, dental work, or tongue. The impact of this rinse on conditions like periodontitis (gum disease) hasn't been fully established, so discussing your oral health and any concerns with your provider is essential for safe and effective treatment.
Storage and Handling
To ensure the best quality and safety of your product, 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), but try to keep it within the recommended limits.
The product comes in a single-dose 0.5 fluid ounce (15 mL) amber plastic bottle, which features a child-resistant dispensing closure for added safety. Always handle the bottle carefully to avoid spills or contamination, and make sure to keep it out of reach of children.
Additional Information
Chlorhexidine Gluconate Oral Rinse is typically used twice daily, right after brushing your teeth, for 30 seconds each time. The usual amount is 15 mL of the undiluted rinse. Be aware that this rinse can cause some tooth discoloration and may lead to an increase in tartar buildup, especially in areas where stains usually form. To keep your teeth healthy, visit your dentist for cleanings at least every six months, or more often if recommended.
If you experience any allergic reactions, such as a rash, difficulty breathing, or rapid heart rate, seek medical help immediately. Additionally, this rinse may alter your taste perception, so it's best to use it after meals and avoid rinsing with water or other mouthwashes right after. Rarely, some users have reported permanent changes in taste or oral discomfort, including swelling of the salivary glands. Regular brushing and flossing can help minimize any discoloration.
FAQ
What is Chlorhexidine Gluconate?
Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate, used for the treatment of gingivitis.
How should I use Chlorhexidine Gluconate Oral Rinse?
You should use 15 mL of undiluted Chlorhexidine Gluconate Oral Rinse twice daily for 30 seconds, 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?
Common side effects include increased staining of teeth, increased calculus formation, and alteration in taste perception.
Who should not use Chlorhexidine Gluconate Oral Rinse?
Chlorhexidine Gluconate should not be used by individuals who are hypersensitive to chlorhexidine gluconate or other ingredients in the formula.
What should I do if I swallow Chlorhexidine Gluconate?
If swallowed, seek medical help or contact a Poison Control Center immediately.
Can Chlorhexidine Gluconate cause staining?
Yes, Chlorhexidine Gluconate can cause staining of oral surfaces, including teeth and restorations.
Is Chlorhexidine Gluconate safe for children?
Use with caution in children, as ingestion can lead to gastric distress. Keep out of reach of children.
What should I do if I experience an allergic reaction?
If you develop symptoms like rash, swelling, or difficulty breathing, seek medical attention immediately.
How should Chlorhexidine Gluconate be stored?
Store Chlorhexidine Gluconate 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).
Packaging Info
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing, Nasal Antisepsis (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 3 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 — Solution
Part 3 — Liquid
| ||||
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing, Nasal Antisepsis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Chlorhexidine Gluconate is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,11-hexamethylene bis5-(p-chlorophenyl) biguanide di-D-gluconate). The formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. This product is characterized as a near-neutral solution, with a pH range of 5 to 7. Chlorhexidine Gluconate is classified 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 product 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.
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 as an oral rinse twice daily. Patients should perform the rinsing for a duration of 30 seconds, ideally in the morning and evening 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 rinse. Chlorhexidine Gluconate Oral Rinse is not intended for ingestion; therefore, 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.
In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.
Warnings and Precautions
The effect of Chlorhexidine Gluconate Oral Rinse on periodontitis has not been established. Clinical studies have indicated an increase in supragingival calculus among users of Chlorhexidine Gluconate Oral Rinse compared to control groups. The impact of this rinse on subgingival calculus remains undetermined. It is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months. Additionally, there have been reports of anaphylaxis and serious allergic reactions associated with dental products containing chlorhexidine; therefore, healthcare professionals should refer to the CONTRAINDICATIONS section for further details.
For patients presenting with both gingivitis and periodontitis, it is important to note that the presence or absence of gingival inflammation following treatment with Chlorhexidine Gluconate Oral Rinse should not be relied upon as a primary indicator of underlying periodontitis.
Chlorhexidine Gluconate Oral Rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical data show that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of Chlorhexidine users developed what was classified as heavy staining, in contrast to only 1% of control users. Staining is more pronounced in individuals with higher plaque accumulation. It is important to note that staining does not adversely affect the health of the gingiva or other oral tissues and can typically be removed through standard professional prophylactic techniques, although additional time may be required. Caution is advised when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins, as natural stains may be difficult to remove and could lead to permanent discoloration, necessitating restoration replacement in rare cases.
Patients may also experience alterations in taste perception during treatment with Chlorhexidine Gluconate Oral Rinse. There have been rare reports of permanent taste alterations following its use, as noted in post-marketing surveillance.
In the event of accidental ingestion, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.
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, oral mucosal side effects were reported at a frequency of less than 1% 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, paresthesia, 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.
It is important to note that Chlorhexidine Gluconate Oral Rinse can cause staining of oral surfaces, with clinical testing indicating that 56% of users exhibited a measurable increase in facial anterior stain compared to 35% of control users after six months. Furthermore, 15% of users developed what was judged to be heavy stain, in contrast to 1% of control users. Rare instances of permanent taste alteration following the use of Chlorhexidine Gluconate Oral Rinse have also been reported through post-marketing surveillance.
Drug Interactions
Chlorhexidine Gluconate Oral Rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other components of the formulation. Serious allergic reactions, including anaphylaxis, have been documented during postmarketing surveillance of dental products containing chlorhexidine.
In terms of drug and laboratory test interactions, the impact of Chlorhexidine Gluconate Oral Rinse on periodontitis remains undetermined. Additionally, it is important to note that the use of this oral rinse may lead to staining of oral surfaces, which includes tooth surfaces, dental restorations, and the dorsum of the tongue. Regular monitoring of oral health and aesthetic considerations may be warranted for patients using this product.
Packaging & NDC
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing, Nasal Antisepsis (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 3 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 — Solution
Part 3 — Liquid
| ||||
Pediatric Use
Chlorhexidine Gluconate Oral Rinse is contraindicated in individuals with known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation.
In pediatric patients, particularly small children weighing approximately 10 kg, ingestion of 1 or 2 ounces may lead to gastric distress, including nausea, or symptoms resembling alcohol intoxication. If more than 4 ounces is ingested or if signs of alcohol intoxication occur, immediate medical attention is necessary.
Caution is advised when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. It is essential to keep this product out of reach of children. In the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.
Geriatric Use
Chlorhexidine Gluconate Oral Rinse does not provide specific information regarding geriatric use. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual patient factors may influence treatment decisions. Regular monitoring and assessment of the patient's response to therapy are advisable, particularly in the absence of specific guidelines for this population.
Pregnancy
Chlorhexidine Gluconate Oral Rinse is contraindicated in individuals with known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. The effects of Chlorhexidine Gluconate Oral Rinse on periodontitis have not been established, and caution is advised due to the potential for serious allergic reactions, including anaphylaxis, which have been reported during postmarketing use of dental products containing chlorhexidine.
Pregnant patients should be aware that Chlorhexidine Gluconate Oral Rinse may lead to staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. Additionally, it may cause tooth discoloration and an increase in tartar (calculus) formation, particularly in areas prone to staining and tartar accumulation. There is also a risk of permanent discoloration of some front-tooth fillings.
Due to the potential for irritation or chemical burns, Chlorhexidine Gluconate Oral Rinse should be used with caution in premature infants or infants under 2 months of age. Healthcare professionals are advised to weigh the benefits against the risks when considering the use of this product in pregnant patients or those who may become pregnant.
Lactation
Chlorhexidine Gluconate Oral Rinse is not intended for ingestion and should be expectorated after rinsing. The effect of Chlorhexidine Gluconate Oral Rinse on nursing mothers and lactation has not been specifically studied. It is not known whether chlorhexidine gluconate is excreted in human milk. Caution should be exercised when administering Chlorhexidine Gluconate Oral Rinse to nursing mothers.
Renal Impairment
There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.
Hepatic Impairment
Patients with hepatic impairment may require careful consideration when using Chlorhexidine Gluconate Oral Rinse. The effect of this oral rinse on periodontitis has not been determined, and it is not known whether 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, which should occur at intervals not greater than six months. Additionally, healthcare providers should remain vigilant for potential adverse reactions, including anaphylaxis and serious allergic reactions, which have been reported during postmarketing use of dental products containing chlorhexidine. Monitoring for these reactions is advised, particularly in patients with a history of allergies or hypersensitivity.
Overdosage
Ingestion of Chlorhexidine Gluconate Oral Rinse in small children can lead to significant adverse effects. Specifically, the consumption of 1 to 2 ounces by a child weighing approximately 10 kg may result in gastric distress, which can manifest as nausea. Additionally, there may be signs indicative of alcohol intoxication due to the formulation of the rinse.
In cases where a small child ingests more than 4 ounces of Chlorhexidine Gluconate Oral Rinse, or if any signs of alcohol intoxication are observed, it is imperative to seek medical attention promptly. Healthcare professionals should be prepared to assess the child’s condition and provide appropriate management to mitigate any potential complications arising from the overdosage.
Nonclinical Toxicology
No information is available regarding teratogenic effects associated with Chlorhexidine Gluconate Oral Rinse.
Chlorhexidine Gluconate Oral Rinse has been associated with non-teratogenic effects, primarily manifesting as staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. While not all patients will experience a visually significant increase in tooth staining, clinical testing has shown that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Additionally, 15% of users developed what was classified as heavy stain, in contrast to only 1% of control users over the same period. It is important to note that the staining resulting from the use of Chlorhexidine Gluconate Oral Rinse does not adversely affect the health of the gingivae or other oral tissues.
Some patients may experience alterations in taste perception during treatment with Chlorhexidine Gluconate Oral Rinse. There have been rare reports of permanent taste alteration following its use, as identified through post-marketing product surveillance.
No information is provided regarding nonclinical toxicology or animal pharmacology and toxicology for Chlorhexidine Gluconate Oral Rinse.
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 voluntarily or through surveillance programs. Additionally, rare instances of permanent taste alteration following the use of Chlorhexidine Gluconate Oral Rinse have been documented.
Among the most frequently reported oral mucosal symptoms associated with Chlorhexidine Gluconate Oral Rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have also been reported in patients using this oral rinse.
Patient Counseling
Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with swallowing the product.
Storage and Handling
The product is supplied in single-dose 0.5 fluid ounce (15 mL) amber plastic bottles, each equipped with child-resistant dispensing closures.
Storage conditions require the product to be maintained 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. Proper handling and storage are essential to ensure the integrity and efficacy of the product.
Additional Clinical Information
Chlorhexidine Gluconate Oral Rinse therapy should commence immediately following dental prophylaxis, with a recommended administration of 15 mL of undiluted rinse twice daily for 30 seconds, ideally in the morning and evening after tooth brushing. Patients are advised to seek medical attention if they experience allergic reactions, which may include symptoms such as skin rash, swelling, breathing difficulties, or gastrointestinal upset.
Clinicians should inform patients that the rinse may lead to tooth discoloration and increased tartar formation, particularly in areas prone to staining. Regular dental visits, at least every six months, are essential for the removal of any stain or tartar. Additionally, patients should be aware that the rinse may cause permanent discoloration of some front-tooth fillings and may alter taste perception. To mitigate these effects, daily brushing and flossing are recommended, and patients should rinse with the oral rinse after meals, avoiding water or other mouthwashes immediately afterward. Post-marketing surveillance has reported rare cases of permanent taste alteration, as well as oral mucosal symptoms such as stomatitis and dry mouth, and instances of parotid gland swelling.
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing, Nasal Antisepsis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.