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Major Oral Rinse

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Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 18, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 18, 2025
Manufacturer
Cardinal Health 107, LLC
Registration number
ANDA077789
NDC root
55154-3573
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 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. This rinse works by being retained in the mouth after rinsing, where it is slowly released to help reduce bacteria and inflammation.

This oral rinse is not absorbed well in the gastrointestinal tract, meaning it mainly acts locally in the mouth. Chlorhexidine gluconate is typically used between dental visits to support gum health and is an important tool in maintaining oral hygiene.

Uses

Chlorhexidine gluconate oral rinse is designed to help you manage gingivitis, which is an inflammation of the gums that can cause redness, swelling, and bleeding when you probe the gums. This rinse is typically used between dental visits as part of a professional treatment program to improve your gum health.

It's important to note that this rinse has not been tested for use in patients with acute necrotizing ulcerative gingivitis (ANUG), a more severe form of gum disease. If you have both gingivitis and periodontitis (another type of gum disease), you should consult your healthcare provider for specific guidance.

Dosage and Administration

After your dental cleaning, you can start using chlorhexidine gluconate oral rinse to help maintain your oral health. You should use it twice a day, in the morning and evening, for 30 seconds each time. The usual amount to use is 15 ml of the rinse, which you should not dilute.

It's important to remember that after using the rinse, you should not rinse your mouth with water or any other mouthwash, brush your teeth, or eat anything right away. Also, make sure to spit out the rinse instead of swallowing it, as it is not meant to be ingested. 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 product is not suitable for individuals with such hypersensitivities, as it may cause adverse reactions.

Additionally, it's important to be aware that chlorhexidine gluconate is a controlled substance, which means it has the potential for abuse or misuse. Always use this medication as directed by your healthcare provider to minimize the risk of dependence (a condition where your body becomes reliant on a substance). If you have any concerns or questions about using this product, please consult your healthcare professional.

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, changes in how things taste, and irritation in your mouth. Some less common oral issues, occurring in fewer than 1% of users, can include mouth ulcers, noticeable gum inflammation, and other conditions affecting the oral mucosa, such as a coated tongue or geographic tongue.

It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic response), 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

When using chlorhexidine gluconate oral rinse, it's important to be aware that its effectiveness on periodontitis (gum disease) has not been established. Some users may experience an increase in supragingival calculus (tartar above the gum line), and while it’s unclear if it affects subgingival calculus (tartar below the gum line), regular dental cleanings should be scheduled every six months to manage any buildup.

Be cautious, as there have been reports of serious allergic reactions, including anaphylaxis (a severe, life-threatening allergic reaction), associated with chlorhexidine dental products. If you experience symptoms such as difficulty breathing, swelling of the face or throat, or a rash, seek emergency help immediately. Additionally, 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. 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

Reproduction studies in animals, such as rats and rabbits, have shown no evidence of harm to the fetus when given chlorhexidine gluconate at high 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 medication during pregnancy only if it is clearly necessary. Always consult with your healthcare provider to weigh the benefits and risks before using any medication while pregnant.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using chlorhexidine gluconate oral rinse, as it is not known whether this medication passes into human milk. Many medications can be found in breast milk, so it's wise to consult your healthcare provider before using this rinse.

In studies involving rats, there were no signs of harm to the mother or her nursing pups when the drug was given in much higher doses than what a human would typically use. However, due to the uncertainty regarding its effects on human milk, you should always prioritize safety and discuss any concerns with your doctor.

Pediatric Use

When considering the use of chlorhexidine gluconate oral rinse for your child, it's important to note that its effectiveness and safety have not been established for children under 18 years old. This means that there is not enough evidence to confirm that it is safe or works well for younger individuals. Always consult with your child's healthcare provider before using this product to ensure it is appropriate for their specific needs.

Geriatric Use

When considering the use of chlorhexidine gluconate oral rinse, it's important to note that its effectiveness and safety have not been established for children under 18 years old. For older adults, there are no specific dosage adjustments or recommendations provided, and the insert does not mention any safety concerns or special precautions for this age group.

This means that if you or a loved one is an older adult, you can use this rinse without additional worries about age-related risks, but it's always a good idea to consult with a healthcare provider before starting any new 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

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20ºC and 25ºC (68ºF to 77ºF). It’s acceptable for the temperature to occasionally range from 15ºC to 30ºC (59ºF to 86ºF), but try to keep it as close to the recommended range as possible.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the 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 rinse with 15 ml of undiluted chlorhexidine gluconate oral rinse twice daily for 30 seconds, after brushing your teeth.

What are the common side effects of chlorhexidine gluconate?

Common side effects include increased staining of teeth, calculus formation, alteration in taste perception, and oral irritation.

Who should not use chlorhexidine gluconate oral rinse?

Chlorhexidine gluconate oral rinse should not be used by individuals who are hypersensitive to chlorhexidine gluconate or any other ingredients in the formula.

Can I use chlorhexidine gluconate oral rinse during pregnancy?

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

Is chlorhexidine gluconate safe for children?

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

What should I do after using chlorhexidine gluconate oral rinse?

After rinsing, do not rinse with water, use other mouthwashes, brush your teeth, or eat immediately.

What should I know about the storage of chlorhexidine gluconate?

Store chlorhexidine gluconate at 20ºC to 25ºC (68ºF to 77ºF), with permitted excursions between 15ºC to 30ºC (59ºF to 86ºF).

Packaging Info

The table below lists all NDC Code configurations of Major Oral Rinse (0.12% chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Major Oral Rinse.
Details

FDA Insert (PDF)

This is the full prescribing document for Major 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 that contains 1, 11-hexamethylene bis 5-(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. Chlorhexidine gluconate is a salt formed from chlorhexidine and gluconic acid, and the product is a near neutral solution with a pH range of 5 to 7.

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 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 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 chlorhexidine gluconate oral rinse. Additionally, healthcare professionals should emphasize that the rinse is not intended for ingestion and must be expectorated following use.

Contraindications

Chlorhexidine gluconate oral rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Use in these patients may lead to adverse reactions due to the potential for allergic responses.

Warnings and Precautions

The effect of chlorhexidine gluconate oral rinse on periodontitis has not been established. Healthcare professionals should be aware that clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users. However, it remains unclear whether the use of this oral rinse contributes to an increase in subgingival calculus.

To mitigate the potential accumulation of calculus, it is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.

Additionally, healthcare providers should remain vigilant for the 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, alterations in taste perception, and oral irritation along with local allergy-type symptoms.

In clinical observations, less than 1% of participants reported oral mucosal side effects, which 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 conditions 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 post-marketing product 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 Major Oral Rinse (0.12% chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Major 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 should be approached with caution, as there is insufficient data to support its efficacy and safety in children and adolescents.

Geriatric Use

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. While there are no specific geriatric use recommendations or dosage adjustments provided for elderly patients, it is important to note that no safety concerns or special precautions for this population are explicitly stated in the prescribing information.

Healthcare providers should continue to monitor geriatric patients as they would with any medication, considering individual patient factors and overall health status when prescribing chlorhexidine gluconate oral rinse.

Pregnancy

Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human response, 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 oral rinse to lactating mothers.

In studies involving parturition and lactation in rats, no evidence of impaired parturition or toxic effects on suckling pups was observed when chlorhexidine gluconate was administered to dams at doses exceeding 100 times the amount that would result from a human ingesting 30 ml of chlorhexidine gluconate oral rinse per day.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

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.

It is crucial for healthcare professionals to be vigilant regarding the amount ingested. If a small child consumes more than 4 ounces of chlorhexidine gluconate oral rinse, or if any signs of alcohol intoxication are observed, immediate medical attention is warranted. Prompt evaluation and management are essential 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 cytogenesis 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. Among the most frequently reported oral mucosal symptoms linked to chlorhexidine gluconate oral rinse 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). Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate rinse.

Patient Counseling

Advise patients that chlorhexidine gluconate oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling, as well as to help control gum bleeding. Patients should be instructed to use the rinse regularly, as directed by their dentist, in conjunction with daily brushing. It is important to remind them to spit out the rinse after use and not to swallow it.

Inform 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. Emphasize 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 chlorhexidine gluconate oral rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. It is essential for patients to visit their dentist for the removal of any stains or tartar at least every six months, or more frequently if advised by their dentist. Both stains and tartar can be effectively removed by a dentist or hygienist. Additionally, inform patients that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.

To help minimize discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration. It is also important to note that chlorhexidine gluconate oral rinse may have a bitter taste and can alter the taste of foods and beverages; however, this effect typically diminishes with continued use.

To avoid interference with taste, patients should be advised to use chlorhexidine gluconate oral rinse after meals and to refrain from rinsing with water or other mouthwashes immediately after using the rinse.

Encourage patients to reach out to their dentist or pharmacist if they have any questions or comments regarding chlorhexidine gluconate oral rinse. They should also be advised to contact their healthcare provider for medical advice concerning any side effects. Patients may report side effects to Xttrium Laboratories at 1-800-587-3721 or to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Temporary excursions are permitted between 15ºC to 30ºC (59ºF to 86ºF), 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 Major Oral Rinse as submitted by Cardinal Health 107, LLC. 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 Major 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 (ANDA077789) 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.

Learn more in our Editorial Policy

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Primary FDA sources:

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.