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Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

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Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
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 2009
Label revision date
April 30, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 1.2 mg/1 mL
Other brand names
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 2009
Label revision date
April 30, 2025
Manufacturer
Xttrium Laboratories, Inc.
Registration number
ANDA077789
NDC root
0116-4075
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

ACClean is an oral rinse that contains 0.12% chlorhexidine gluconate, a compound that helps manage oral health. It is primarily used between dental visits as part of a professional program to treat gingivitis, which is characterized by symptoms such as redness, swelling of the gums, and bleeding when probing the gums.

This rinse works by reducing the bacteria in your mouth, helping to alleviate the symptoms of gingivitis and promote better gum health. It's important to use ACClean as directed by your dental professional to achieve the best results in maintaining your 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. For the best results, rinse with 15 ml (which is marked in the cap) of the undiluted solution twice a day—once in the morning and once in the evening—after you brush your teeth. Make sure to swish the rinse 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 right away. 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 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 hypersensitivity, 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. If you have concerns about dependence (a condition where your body becomes reliant on a substance), please discuss them with your healthcare provider. Always follow your doctor's instructions and do not use this rinse if you have any known allergies to its components.

Side Effects

You may experience some common side effects while using this medication, including increased staining of your teeth and other oral surfaces, changes in taste perception, and oral irritation. You might also notice an increase in calculus (tartar) formation and local allergy-type symptoms.

In rare cases, more serious oral mucosal side effects have been reported, such as ulcers, gingivitis (inflammation of the gums), and dry mouth. There have also been instances of swelling in the salivary glands and serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction). If you notice any unusual or persistent 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 buildup.

Be cautious, as serious allergic reactions, including anaphylaxis (a severe, life-threatening allergic response), have been reported with this product. If you experience any signs of an allergic reaction, such as difficulty breathing, swelling of the face or throat, or hives, seek emergency help immediately. Additionally, 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 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 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.

In studies involving rats, there were no signs of problems during childbirth or harmful effects on nursing pups when the mothers were given doses much higher than what a human would typically use (over 100 times more than the equivalent of 30 ml, or 2 capfuls, per day). 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 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. Unfortunately, there is no specific information available regarding its use in older adults, including any necessary dosage adjustments or safety concerns.

If you are caring for an older adult, it's always best to consult with a healthcare professional before starting any new treatment. They can provide guidance tailored to individual health needs and ensure that any potential risks are managed appropriately.

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 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 liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 any concerns about allergies or reactions to medications, it's crucial to discuss these with your healthcare provider.

Additionally, the effectiveness of chlorhexidine gluconate oral rinse in treating periodontitis (a serious gum infection) has not been established. Always consult with your healthcare provider about any medications or tests you are considering, as they can help ensure your safety and the best possible outcomes for your health.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). The product comes in amber plastic bottles, available in sizes of 4 ounces (118 ml) and 1 pint (473 ml), which are designed with child-resistant closures for added safety.

When handling the product, make sure to keep it in a clean environment to maintain its integrity. Always ensure that the closures are securely fastened after use to prevent any accidental access, especially by children.

Additional Information

You should use chlorhexidine gluconate oral rinse twice daily, rinsing for 30 seconds each time, in the morning and evening after brushing your teeth. The usual dosage is 15 ml (which is marked in the cap) of the undiluted rinse. It's important not to rinse with water, use other mouthwashes, brush your teeth, or eat immediately after using the rinse.

If you're using this oral rinse, make sure to have a dental check-up and thorough cleaning at least every six months. Be aware that some people have experienced serious allergic reactions, including anaphylaxis, after using products with chlorhexidine. Other reported side effects include various oral issues like mouth sores, gum inflammation, and dry mouth. If you notice any unusual symptoms, consult your healthcare provider.

FAQ

What is ACCLEAN?

ACDCLEAN 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 chlorhexidine gluconate oral rinse?

Do not rinse with water, use other mouthwashes, brush your teeth, or eat immediately after using the rinse.

Who should not use chlorhexidine gluconate oral rinse?

It should not be used by individuals who are hypersensitive to chlorhexidine gluconate or other ingredients in the formula.

What are 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 chlorhexidine gluconate oral rinse be used 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 oral rinse safe for nursing mothers?

It is not known if chlorhexidine gluconate is excreted in human milk, so caution is advised when administered to nursing women.

What should I do if I experience severe allergic reactions?

Seek immediate medical attention if you experience anaphylaxis or serious allergic reactions after using chlorhexidine gluconate oral rinse.

How should I store chlorhexidine gluconate oral rinse?

Store the rinse at 20°C to 25°C (68°F-77°F), with excursions permitted between 15°C to 30°C (59°F-86°F).

What is the usual dosage for chlorhexidine gluconate oral rinse?

The usual dosage is 15 ml, marked in the cap, of undiluted rinse.

Packaging Info

The table below lists all NDC Code configurations of Acclean 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.

Packaging configurations for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse.
Details

FDA Insert (PDF)

This is the full prescribing document for Acclean 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.

View FDA-approved insert (PDF)

Description

ACCCLEAN is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis 5-(p-chlorphenyl) biguanide di-D-gluconate). The product is presented in a base that includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavoring agents, sodium saccharin, and FD&C Blue No. 1. The chlorhexidine gluconate solution is characterized by a near-neutral pH, ranging from 5 to 7. Chlorhexidine gluconate itself is 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.

This product has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, healthcare professionals should refer to the PRECAUTIONS section for further guidance.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 15 ml of undiluted chlorhexidine gluconate oral rinse, as indicated by the markings on the cap. Patients are advised to use the rinse twice daily, specifically in the morning and evening, for a duration of 30 seconds after brushing their teeth.

It is essential that patients do not rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the chlorhexidine gluconate oral rinse. Additionally, this product is not intended for ingestion; patients should expectorate the rinse after 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 severe allergic reactions.

Warnings and Precautions

The effect of chlorhexidine gluconate oral rinse on periodontitis has not been established. Clinicians should be aware that an increase in supragingival calculus has been observed in users of chlorhexidine gluconate oral rinse compared to control groups during clinical testing. 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.

Healthcare professionals should also be vigilant for the occurrence of anaphylaxis and other serious allergic reactions, which have been reported in postmarketing experiences with dental products containing chlorhexidine. For further details, please refer to the contraindications section.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, alterations in taste perception, oral irritation, and local allergy-type symptoms.

In clinical trials, several oral mucosal side effects were reported among participants, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. These events occurred at a frequency of less than 1%.

Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been noted.

Serious adverse reactions include cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis). Anaphylaxis and other serious allergic reactions have been reported during postmarketing use. Furthermore, there have been rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse.

Drug Interactions

Serious allergic reactions, including anaphylaxis, have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of hypersensitivity in patients using these products and take appropriate action if such reactions occur.

The impact of chlorhexidine gluconate oral rinse on periodontitis has not been established. Therefore, clinicians should exercise caution when considering its use for this indication and may need to monitor patients closely for any changes in their condition.

Packaging & NDC

The table below lists all NDC Code configurations of Acclean 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.

Packaging configurations for Acclean Chlorhexidine Gluconate 0.12% 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 is no specific information available regarding the use of this product in geriatric patients, including any recommendations for dosage adjustments or safety considerations.

Healthcare providers should exercise caution when prescribing chlorhexidine gluconate oral rinse to elderly patients, given the lack of established data in this population. Monitoring for any adverse effects or complications is advisable, as the absence of specific geriatric use information necessitates a careful assessment of individual patient needs and responses to treatment.

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

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

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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 these studies included 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. Furthermore, there was no evidence of impaired fertility in rats at doses up to 100 mg/kg/day. No information is available regarding teratogenic effects or additional animal pharmacology and toxicology data.

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. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.

Patient Counseling

Healthcare providers should advise patients that chlorhexidine gluconate oral rinse is contraindicated for individuals who are hypersensitive to chlorhexidine gluconate or any other ingredients in the formulation. It is important to inform patients that the use of this oral rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical studies indicate that 56% of users exhibited a measurable increase in facial anterior stain after six months, with 15% developing what was considered heavy stain.

Providers should reassure patients that staining does not adversely affect the health of the gingivae or other oral tissues and can typically be removed through standard professional dental cleaning techniques. Caution should be exercised when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins, as natural stains may not be removable, and permanent discoloration could be unacceptable to some patients.

Patients may also experience alterations in taste perception during treatment, and rare cases of permanent taste changes have been reported. It is recommended that chlorhexidine gluconate oral rinse therapy be initiated immediately following a dental prophylaxis, with patients being reevaluated and receiving thorough prophylaxis at intervals not exceeding six months.

The recommended usage involves rinsing twice daily for 30 seconds, both in the morning and evening, after brushing teeth, using a dosage of 15 ml of undiluted rinse as marked in the cap. Patients should be instructed not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using the rinse. It is crucial to emphasize that chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after use.

Providers should also inform caregivers that ingestion of 1 or 2 ounces of the rinse by a small child (approximately 10 kg body weight) may lead to gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if a small child ingests more than 4 ounces or exhibits signs of alcohol intoxication.

Storage and Handling

The product is supplied in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles, each equipped with child-resistant closures.

Storage conditions require the product to be maintained at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). Proper handling and storage within these specified temperature limits are essential to ensure product integrity and efficacy.

Additional Clinical Information

Patients using chlorhexidine gluconate oral rinse are advised to rinse twice daily for 30 seconds, both in the morning and evening, after brushing their teeth. The usual dosage is 15 ml of undiluted rinse, and patients should refrain from rinsing with water, using other mouthwashes, brushing their teeth, or eating immediately after administration. It is recommended that patients be reevaluated and receive thorough prophylaxis at intervals not exceeding six months, with therapy initiated directly following a dental prophylaxis.

Postmarketing experience has revealed reports of anaphylaxis and serious allergic reactions associated with dental products containing chlorhexidine. Common oral mucosal symptoms reported include stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented in patients using the oral rinse.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Xttrium Laboratories, Inc.. 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 Acclean Chlorhexidine Gluconate 0.12% 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.

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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.