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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 3, 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 3, 2025
Manufacturer
Major Pharmaceuticals
Registration number
ANDA077789
NDC root
0904-7035
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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, at a concentration of 0.12%, is a specialized mouthwash designed to help manage gingivitis, which is the inflammation of the gums often characterized by redness, swelling, and bleeding. This rinse contains chlorhexidine gluconate, a compound that works by being retained in the mouth after rinsing, where it is slowly released to help reduce bacteria and promote oral health.

This oral rinse is typically used between dental visits as part of a professional treatment program for gingivitis. It is important to note that chlorhexidine gluconate is not absorbed well by the body and is primarily eliminated through the feces, making it effective for localized treatment in the mouth without significant systemic absorption.

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. You should use it twice a day, once in the morning and once in the evening, right after brushing your teeth. For each rinse, measure out 15 ml of the undiluted solution and swish it around in your mouth for 30 seconds.

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 immediately. Also, keep in mind that this rinse is not meant to be swallowed; you should 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 allergic to chlorhexidine gluconate or any of the other ingredients in the oral rinse, you should not use this product. Allergic reactions can be serious, so it's important to avoid using it if you have a known hypersensitivity. Always consult with your healthcare provider if you have any concerns about your allergies or the ingredients in medications.

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, oral irritation, and local allergy-like symptoms. In rare cases (less than 1% of users), you might also notice issues such as mouth ulcers, gingivitis (gum inflammation), or a coated tongue.

There have been reports of more serious reactions, including anaphylaxis (a severe allergic reaction) and other allergic responses. Additionally, some users have experienced dry mouth, swelling of the salivary glands, and changes in taste perception, which can sometimes be permanent. If you notice any unusual symptoms, it's important to consult your healthcare provider.

Warnings and Precautions

When using chlorhexidine gluconate oral rinse, it's important to be aware that its effectiveness on periodontitis (gum disease) has not been established. 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 deposits.

You should also be cautious of potential allergic reactions. Anaphylaxis (a severe, life-threatening allergic reaction) and other serious allergies 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. Additionally, if you notice any unusual reactions 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. Always err on the side of caution when it comes to your child's health.

Pregnancy Use

Reproduction studies in rats and rabbits have shown that chlorhexidine gluconate, even at high doses, did not harm the fetus. 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 your healthcare provider to discuss the potential risks and benefits 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 conducted on rats, there were no signs of harm to nursing pups or issues with childbirth when the mothers were given doses much higher than what a human would typically use. However, since the effects on human milk are still unclear, always prioritize safety and seek professional advice regarding any medications while breastfeeding.

Pediatric Use

When considering the use of chlorhexidine gluconate oral rinse for your child, it's important to note that its effectiveness and safety have not been established for children under 18 years old. This means that there 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 oral rinse, it's important to note that its effectiveness and safety have not been established for children under 18 years old. For older adults, there are no specific recommendations or dosage adjustments mentioned in the available information. This means that while the product may be used, it is essential to consult with a healthcare provider to ensure it is appropriate for your individual health needs. Always prioritize open communication with your doctor about any concerns or questions regarding 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 standard recommendations for the medication do not change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance based on your individual situation.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place 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 Oral Rinse USP, 0.12%?

Chlorhexidine Gluconate Oral Rinse USP, 0.12% 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 rinse with 15 ml of undiluted chlorhexidine gluconate oral rinse for 30 seconds, twice daily, after brushing your teeth.

What should I avoid after using the 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 Oral Rinse?

Common side effects include increased staining of teeth, alteration in taste perception, oral irritation, and local allergy-type symptoms.

Can I use Chlorhexidine Gluconate Oral Rinse if I am pregnant?

Chlorhexidine gluconate should be used during pregnancy only 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 oral rinse have not been established in children under the age of 18.

What should I do if I experience an allergic reaction?

If you experience anaphylaxis or serious allergic reactions, seek immediate medical attention.

How is Chlorhexidine Gluconate absorbed and excreted in the body?

Chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract, with about 90% excreted through feces and less than 1% in urine.

What is the recommended storage condition for Chlorhexidine Gluconate Oral Rinse?

Store the rinse at 20ºC to 25ºC (68ºF to 77ºF), with excursions permitted 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 it is presented as a near neutral solution with a pH range of 5-7.

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, 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, to be used twice daily. Patients should perform the rinsing for 30 seconds in the morning and evening, after brushing their teeth.

It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the chlorhexidine gluconate oral rinse. The 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 exercise caution, as anaphylaxis and serious allergic reactions have been reported in postmarketing experiences with dental products containing chlorhexidine. Monitoring for signs of hypersensitivity is advised during treatment.

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, alteration in taste perception, oral irritation, and local allergy-type symptoms.

In clinical trials, oral mucosal side effects were reported at a frequency of less than 1% among participants. These 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. Patients should be aware that some may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration documented through post-marketing 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. However, there are no specific recommendations, dosage adjustments, or safety concerns noted for elderly patients.

Healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate oral rinse in geriatric patients, as individual patient factors may influence treatment outcomes. Monitoring for any adverse effects is advisable, given the lack of established data in this population.

Pregnancy

Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human responses, this drug should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 for potential complications and provide appropriate management based on the severity of the symptoms presented.

Nonclinical Toxicology

In a drinking water study conducted in rats, no carcinogenic effects were observed at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies involving chlorhexidine gluconate. The highest doses administered in 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 while helping to control gum bleeding. It is essential for patients to use the oral rinse regularly as directed, in conjunction with daily brushing. Instruct them to spit out the rinse after use and to avoid swallowing 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 the rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. It is important for them to visit their dentist for the removal of any stain or tartar at least every six months, or more frequently if advised by their dentist. Both stain and tartar can be effectively removed by a dentist or hygienist. Additionally, inform patients that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.

To minimize the risk of discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration. They may find that the rinse has a bitter taste and can alter the taste of foods and beverages; however, this effect typically diminishes with continued use. To reduce taste interference, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals.

Instruct patients not to rinse with water or other mouthwashes immediately after using chlorhexidine gluconate oral rinse. Encourage them to reach out to their dentist or pharmacist with any questions or comments regarding the oral rinse. For medical advice about side effects, patients should contact their healthcare provider. They may also 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 Major 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 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.