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Dash Chlorhexidine Gluconate 0.12% 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 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
- Liquid
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2018
- Label revision date
- September 30, 2025
- 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 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
- Liquid
- 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 2018
- Label revision date
- September 30, 2025
- Manufacturer
- Cardinal Health 107, LLC
- Registration number
- ANDA074291
- NDC root
- 55154-1981
- 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 specialized mouthwash that contains 0.12% chlorhexidine gluconate, a compound designed to help 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 helps reduce bacteria and promote healthier gums.
When you use this oral rinse, about 30% of the active ingredient remains in your mouth, allowing it to gradually work over time. Chlorhexidine gluconate is not significantly absorbed into the body, meaning it primarily acts locally in your mouth to support your dental care routine.
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, especially when your gums are probed during dental check-ups. This rinse is typically used between your dental visits as part of a professional treatment plan to improve your gum health.
It's important to note that Chlorhexidine Gluconate has not been tested for effectiveness in patients with acute necrotizing ulcerative gingivitis (ANUG), a more severe form of gum disease. Always consult with your dentist to determine the best treatment options for your specific needs.
Dosage and Administration
After your dental cleaning, you can start using Chlorhexidine Gluconate Oral Rinse to help maintain your oral health. For the best results, rinse your mouth twice a day—once in the morning and once in the evening—after you brush your teeth. Use 15 ml of the rinse, which is the amount marked in the cap, and swish it around in your mouth for 30 seconds.
It's important to remember that you should not rinse your mouth with water or any other mouthwash, brush your teeth, or eat anything right 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
It’s important to be cautious when using this product. You should not use it if you are known to be hypersensitive (having an extreme reaction) to chlorhexidine gluconate or any other ingredients in the formula. Doing so could lead to serious allergic reactions.
Additionally, be aware that this product is classified as a controlled substance, which means it has the potential for abuse or misuse. If you have concerns about dependence (a condition where your body relies on a substance), please discuss them with your healthcare provider. Always follow your healthcare provider's instructions and avoid using this product if you have any of the mentioned sensitivities.
Side Effects
You may experience some common side effects while using this product, including 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% of users), you might also notice issues like mouth ulcers, gingivitis (gum inflammation), or a coated tongue.
There are also some less common effects reported after the product has been on the market, such as dry mouth, swelling of the salivary glands, and irritation of the oral mucosa. It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction), have been reported. If you notice any unusual symptoms, please 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 oral 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
If you are pregnant or planning to become pregnant, it's important to know that this medication is classified as pregnancy category B. This means that studies in animals, such as rats and rabbits, have not shown any harm to the fetus at certain doses. However, there have not been adequate and well-controlled studies in pregnant women.
Because animal studies do not always predict how humans will respond, you should only use this medication during pregnancy if it is clearly necessary. Always consult with your healthcare provider to discuss the potential risks and benefits before starting any new medication while pregnant.
Lactation Use
It is currently unclear whether chlorhexidine gluconate, a common antiseptic, 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 its use.
In studies involving rats, there were no signs of negative effects on childbirth or harm to nursing pups when the mothers were given doses significantly higher than what a person 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 for your child, it's important to note that its effectiveness and safety have not been established for anyone under 18 years old. This means that there isn't enough research 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, 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 and circumstances. Always prioritize open communication with your doctor about any concerns or questions you may have regarding medications.
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 and what steps to take for your safety.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment is safe and effective.
Always feel free to ask questions and share all the medications, supplements, and tests you are using. This way, your healthcare team can provide the best care tailored to your needs.
Storage and Handling
To ensure the safety and effectiveness of your product, store it at a temperature between 20°-25°C (68°-77°F). It’s acceptable for the temperature to occasionally range from 15°-30°C (59°-86°F). Always keep the product in its original container or transfer it to amber glass bottles, which help protect it from light.
Additionally, it's crucial to keep this product and all medications out of the reach of children to prevent accidental ingestion. Following these guidelines will help maintain the quality and safety of the product.
Additional Information
No further information is available.
FAQ
What is Chlorhexidine Gluconate 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, which includes symptoms like redness, swelling, and gingival bleeding.
How should I use Chlorhexidine Gluconate Oral Rinse?
You should use 15ml of the rinse twice daily for 30 seconds, after brushing your teeth. Do not rinse with water or other mouthwashes, brush your teeth, or eat immediately after using it.
What are the common side effects of Chlorhexidine Gluconate Oral Rinse?
Common side effects include increased staining of teeth, increased calculus formation, and alteration in taste perception.
Can I use Chlorhexidine Gluconate Oral Rinse if I am pregnant?
Chlorhexidine Gluconate is classified as pregnancy category B, meaning it should only be used during pregnancy 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 have not been established in children under the age of 18.
What should I do if I experience an allergic reaction?
If you experience symptoms of anaphylaxis or serious allergic reactions, seek immediate medical attention.
How should I store Chlorhexidine Gluconate Oral Rinse?
Store the rinse at 20°-25°C (68°-77°F) and keep it out of the reach of children.
What should I avoid while using Chlorhexidine Gluconate Oral Rinse?
Avoid rinsing with water, using other mouthwashes, brushing your teeth, or eating immediately after using the rinse.
Packaging Info
The table below lists all NDC Code configurations of Dash Chlorhexidine Gluconate 0.12% Oral Rinse (chlorhexidine gluconate 0.12% oral rinse), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid | 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 Dash Chlorhexidine Gluconate 0.12% 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
This product is an oral rinse containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanidedi-0-gluconate) in a base that includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint oil, saccharin sodium, and FD&C Blue #1. The pH of the solution is near-neutral, ranging from 5 to 7, and may be adjusted with hydrochloric acid or sodium hydroxide. Chlorhexidine gluconate is a salt formed from chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N10•2C6H12O7 and a molecular weight of 897.77.
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. This condition is characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.
Limitations of Use: Chlorhexidine gluconate has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). Therefore, its use in this population is not recommended.
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, which should be administered twice daily. Patients are advised to perform oral rinsing for 30 seconds in the morning and evening, following tooth brushing.
It is essential that patients do not rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion; therefore, it should be expectorated after rinsing to ensure proper use and effectiveness.
Contraindications
Use of this product is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Due to the potential for severe allergic reactions, such patients should avoid this product to prevent adverse effects.
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 alterations in taste perception.
In clinical trials, oral mucosal side effects were reported in less than 1.0% 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 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 alterations in taste perception during treatment, with rare instances of permanent taste alteration noted in postmarketing surveillance.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Dash Chlorhexidine Gluconate 0.12% Oral Rinse (chlorhexidine gluconate 0.12% oral rinse), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid | 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 have not been established in pediatric patients under the age of 18. Therefore, caution is advised when considering its use in this population.
Geriatric Use
Clinical effectiveness and safety of chlorhexidine gluconate have not been established in children under the age of 18. For elderly patients, there are no specific recommendations regarding geriatric use, dosage adjustments, or safety concerns noted in the available data. Therefore, healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate in this population, taking into account individual patient factors and potential risks. Monitoring for any adverse effects is advisable, as with any medication administered to geriatric patients.
Pregnancy
Pregnancy category B indicates that 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 fetal harm. However, it is important to note that adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human outcomes, 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 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 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 (2 capfuls) 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.
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 outlined 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 can lead to significant adverse effects, particularly in small children. 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 symptoms resembling alcohol intoxication.
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 based on the severity of the symptoms presented.
Nonclinical Toxicology
Pregnancy category B has been assigned to this drug based on the results of reproduction studies conducted in rats and rabbits. These studies administered chlorhexidine gluconate at doses of up to 300 mg/kg/day in rats and 40 mg/kg/day in rabbits, revealing no evidence of harm to the fetus. However, it is important to note that adequate and well-controlled studies in pregnant women have not been performed. Given that animal reproduction studies may not always predict human responses, the use of this drug during pregnancy should be considered only when clearly necessary.
In terms of non-teratogenic effects, no evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.
Carcinogenicity assessments conducted in a drinking water study in rats indicated that 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 a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively.
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 oral mucosal symptoms frequently noted are stomatitis, gingivitis, glossitis, ulcers, 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) in patients utilizing chlorhexidine gluconate oral rinse. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through postmarketing product surveillance.
Patient Counseling
Patients should be informed 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. It is essential for patients to use the rinse regularly as directed by their dentist, in conjunction with daily brushing. Patients should be advised to spit out the rinse after use and to avoid swallowing it.
Healthcare providers should counsel patients to seek immediate medical attention if they experience any allergic symptoms, which may include skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. It is important to note that Chlorhexidine Gluconate Oral Rinse should not be used by individuals who have a known sensitivity to it or its components.
Patients should be made aware that the use of Chlorhexidine Gluconate Oral Rinse may lead to tooth discoloration and an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are recommended 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. Additionally, patients should be informed 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 maintain a daily brushing and flossing routine, paying special attention to areas that begin to show discoloration. It is also important to inform patients that the rinse may have a bitter taste and can alter the taste of foods and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, patients should be advised to use the rinse after meals and to refrain from rinsing with water or other mouthwashes immediately afterward.
Patients are encouraged to reach out to their dentist or pharmacist with any questions or comments regarding Chlorhexidine Gluconate Oral Rinse. They should also be instructed to contact their healthcare provider for medical advice concerning any side effects experienced. Side effects can be reported to the FDA at 1-800-FDA-1088. Lastly, patients should be reminded to keep this and all medications out of the reach of children.
Storage and Handling
The product is supplied in its original container or in amber glass bottles. It should be stored at a temperature range of 20°-25°C (68°-77°F), with permissible excursions between 15°-30°C (59°-86°F) as defined by USP Controlled Room Temperature guidelines. It is essential to keep this product, along with all medications, out of the reach of children.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Dash Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Cardinal Health 107, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.