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Chlorhexidine gluconate

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Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
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 2023
Label revision date
February 10, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
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 2023
Label revision date
February 10, 2025
Manufacturer
Brisk Pharmaceuticals
Registration number
ANDA075561
NDC root
73614-203
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 is an oral rinse that contains a compound designed to help manage oral health, particularly for individuals dealing with gingivitis, which is characterized by redness, swelling, and bleeding of the gums. This rinse is typically used between dental visits as part of a professional treatment program to reduce these symptoms and improve gum health.

When you use chlorhexidine gluconate, about 30% of the active ingredient remains in your mouth after rinsing, allowing it to be slowly released into your saliva. This helps to maintain its effectiveness in combating the signs of gingivitis. It's important to note that chlorhexidine gluconate is not absorbed well by the body and is primarily 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 acute necrotizing ulcerative gingivitis (ANUG), a more severe form of gum disease. If you have both gingivitis and periodontitis (a more advanced 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. 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 (which is marked in the cap) 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 right after using the chlorhexidine rinse. Also, this rinse is not meant to be swallowed, so make sure to spit it out after rinsing. Following these steps will help you get the most benefit from your oral rinse therapy.

What to Avoid

If you are sensitive to chlorhexidine gluconate or any of the other ingredients in the oral rinse, you should avoid using it. This is important to prevent any allergic reactions or adverse effects. Additionally, be aware that this product is classified as a controlled substance, which means it has specific regulations regarding its use.

It's crucial to use this rinse only as directed and to avoid any misuse or abuse, as this can lead to dependence (a condition where you may feel unable to function without the substance). Always consult with your healthcare provider if you have any concerns or questions about using this product safely.

Side Effects

You may experience some common side effects while using this product, 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% of users), you might also notice issues like mouth ulcers, gingivitis (gum inflammation), or a coated tongue.

There are additional side effects that have been reported after the product has been on the market, including dry mouth, oral irritation, and swelling of the salivary glands. It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction), have occurred in some users. 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 should be scheduled every six months to manage any buildup.

You should also be cautious of potential allergic reactions. Anaphylaxis (a severe, life-threatening allergic reaction) and other serious allergic responses have been reported with chlorhexidine products. If you experience symptoms like difficulty breathing, swelling of the face or throat, or a rash, seek emergency help immediately. If you notice any unusual reactions or side effects 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. 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 oral 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

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 have shown no harmful effects on childbirth or nursing pups when the mothers were given doses much higher than what a human would typically use (about 30 mL or 2 capfuls per day). However, always consult your healthcare provider before using any medication while breastfeeding to ensure the safety of you and your baby.

Pediatric Use

It's important to know that the effectiveness and safety of chlorhexidine gluconate oral rinse have not been proven for children under 18 years old. This means that if you are considering this treatment for your child, there isn't enough evidence to ensure it will work safely for them. Always consult with your child's healthcare provider for the best options tailored to their age and health needs.

Geriatric Use

When considering the use of chlorhexidine gluconate oral rinse for older adults, it's important to be aware of a few key points. This rinse has not been tested for safety and effectiveness in children under 18, so it’s primarily intended for adults. If you are a nursing woman, caution is advised when using this product.

You may notice some common side effects, such as increased staining of your teeth and changes in how things taste. In rare cases, some people have reported lasting changes in taste after using the rinse. If you have dental work, especially with rough surfaces, be cautious, as the rinse can cause permanent discoloration that may be hard to remove. If you have concerns about staining or your dental restorations, it’s best to discuss these with your dentist before starting treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

It's important to be aware that the effects of chlorhexidine gluconate oral rinse on periodontitis (gum disease) have not been established. Additionally, it is unclear whether using this rinse leads to an increase in subgingival calculus (tartar below the gum line). If you have liver problems, please consult your healthcare provider before using this product, as they can guide you on its safety and any necessary adjustments.

Be cautious, as there have been reports of serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction), associated with dental products containing chlorhexidine. If you experience any unusual symptoms after using the rinse, seek medical attention immediately.

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 between other drugs or laboratory tests and chlorhexidine. However, always consult with your healthcare provider about any medications or tests you are undergoing to avoid potential issues and to receive personalized advice tailored to your health 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). The rinse comes in a blue liquid form, packaged in 1-pint (473 mL) amber plastic bottles that have child-resistant closures, along with 15 mL unit-dose cups for easy use.

When handling the oral rinse, make sure to keep it in a safe place, out of reach of children, to prevent accidental ingestion. Always check the packaging for any specific disposal instructions to ensure safe disposal of any unused product.

Additional Information

No further information is available.

FAQ

What is chlorhexidine gluconate?

Chlorhexidine gluconate is an oral rinse containing 0.12% chlorhexidine gluconate, a salt of chlorhexidine and gluconic acid, used for treating 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, and avoid rinsing with water or eating immediately after.

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.

Is chlorhexidine gluconate safe to use during pregnancy?

Chlorhexidine gluconate should be used during pregnancy only if clearly needed, as adequate studies in pregnant women have not been conducted.

Can I use chlorhexidine gluconate if I have allergies?

You should not use chlorhexidine gluconate if you are known to be hypersensitive to it or any of its ingredients.

What should I do if I experience side effects?

If you experience side effects such as oral irritation or allergic reactions, consult your healthcare provider for advice.

Is chlorhexidine gluconate effective for children?

The clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under 18 years of age.

How should I store chlorhexidine gluconate oral rinse?

Store chlorhexidine gluconate oral rinse at 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

Packaging Info

The table below lists all NDC Code configurations of Chlorhexidine Gluconate Oral Rinse, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Chlorhexidine Gluconate Oral Rinse.
Details

FDA Insert (PDF)

This is the full prescribing document for Chlorhexidine Gluconate 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.

View FDA-approved insert (PDF)

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.

Limitations of Use: Chlorhexidine gluconate oral rinse has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients with coexisting gingivitis and periodontitis, refer to the PRECAUTIONS section for additional guidance.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 15 mL of undiluted chlorhexidine gluconate oral rinse, which is to be marked in the cap. Patients should perform oral rinsing twice daily for 30 seconds, specifically 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 chlorhexidine gluconate oral rinse. Additionally, it should be emphasized that the rinse is not intended for ingestion and must be expectorated following the rinsing procedure.

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, oral mucosal side effects were reported in less than 1% of participants and included aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing reports have identified additional oral mucosal symptoms, which are among the most frequently reported. These include stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Other side effects noted include oral irritation, local allergy-type symptoms, minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

Serious adverse reactions, such as anaphylaxis and other serious allergic reactions, have been reported during postmarketing use of dental products containing chlorhexidine. Furthermore, some patients may experience a permanent alteration in taste perception, which has been documented in rare instances through post-marketing product surveillance.

Drug Interactions

Anaphylaxis and serious allergic reactions have been reported in postmarketing use associated with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of these reactions in patients using such products.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not indicated at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Chlorhexidine Gluconate Oral Rinse, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Chlorhexidine Gluconate Oral Rinse.
Details

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 established data may impact therapeutic decisions.

Geriatric Use

Caution should be exercised when administering chlorhexidine gluconate oral rinse to elderly patients, particularly those aged 65 and older. The clinical effectiveness and safety of this oral rinse have not been established in individuals under the age of 18, which may suggest a need for careful consideration of its use in geriatric populations.

Elderly patients may experience common side effects associated with chlorhexidine gluconate oral rinse, including an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. It is important to monitor these patients for such effects, as some may experience a temporary alteration in taste perception during treatment. Additionally, rare instances of permanent taste alteration have been reported through post-marketing surveillance, warranting further caution in this demographic.

When prescribing chlorhexidine gluconate oral rinse to geriatric patients, discretion is advised, especially for those with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces through dental prophylaxis, it may be prudent to exclude these patients from treatment with chlorhexidine gluconate oral rinse, particularly if permanent discoloration is deemed unacceptable. Stains in these areas can be challenging to remove and, in rare cases, may necessitate the replacement of restorations. Therefore, careful assessment and monitoring are essential when considering the use of this oral rinse in elderly patients.

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, there is a lack of adequate and well-controlled studies in pregnant women. Due to the limitations of animal reproduction studies in predicting human responses, chlorhexidine gluconate should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of this drug in pregnant patients.

Lactation

It is not known whether chlorhexidine gluconate is excreted in human milk. Due to the potential for many drugs to be excreted in breast milk, caution should be exercised when administering chlorhexidine gluconate oral rinse to lactating mothers.

In animal 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 (2 capfuls) of the oral rinse per day.

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 treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be monitored closely when using chlorhexidine gluconate oral rinse, as the effects of the rinse on periodontitis in this population have not been determined. Additionally, it is not known whether the use of chlorhexidine gluconate oral rinse results in an increase in subgingival calculus in patients with compromised liver function.

Due to the potential for serious allergic reactions, including anaphylaxis, which have been reported during postmarketing use of dental products containing chlorhexidine, healthcare providers should exercise caution and consider the risk-benefit profile when prescribing this product to patients with hepatic impairment. Regular assessment of liver function may be warranted to ensure patient safety.

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 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 potential complications associated with overdosage.

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 a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. Furthermore, no evidence of impaired fertility was noted in rats at doses up to 100 mg/kg/day.

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, oral irritation and local allergy-type symptoms have been spontaneously noted as side effects of chlorhexidine gluconate rinse.

Among the most frequently reported oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, 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, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented. Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been reported through post-marketing 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 oral rinse regularly, as directed by their dentist, and to continue their daily brushing routine.

Patients must be advised to spit out the rinse after use, as chlorhexidine gluconate oral rinse should not be swallowed. They should be made aware of the potential for allergic reactions, which may include symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. In such cases, patients should seek medical attention immediately.

It is important to inform patients that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components. Patients should also be made aware that the rinse may lead to tooth discoloration or 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 crucial, with a recommendation to see their dentist at least every six months, or more frequently if advised.

Patients should be cautioned that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, they should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration. Additionally, patients may experience a bitter taste from the rinse, which can affect the taste of food and beverages; however, this effect typically diminishes with continued use. To mitigate taste interference, it is advisable for patients to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should be encouraged to contact their dentist or pharmacist, or reach out to Rising Pharma Holdings, Inc. at 1-844-874-7464. Patients should also be advised to call their healthcare provider for medical advice regarding side effects and to report any adverse effects to the FDA at 1-800-FDA-1088.

Storage and Handling

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles equipped with child-resistant closures, as well as in 15 mL unit-dose cups.

It is recommended to store the product 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 storage conditions are essential to maintain 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 Oral Rinse as submitted by Brisk Pharmaceuticals. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Chlorhexidine Gluconate Oral Rinse, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA075561) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.