Drugplain

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL

Chlorhexidine Gluconate 0.12% Oral Rinse · LIQUID · Xttrium Laboratories, Inc.

No Recall History
Plain English

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse is a liquid containing chlorhexidine gluconate 0.12% oral rinse at 1.2 mg/mL, taken oral. Manufactured by Xttrium Laboratories, Inc..

Key Facts

Brand Name
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse
Generic Name
Chlorhexidine Gluconate 0.12% Oral Rinse
NDC Code (Product)
0116-4075
Manufacturer
Xttrium Laboratories, Inc.
Strength
1.2 mg/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
ANDA077789
Marketing Start
10/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

oral discomfort4 reports
recalled product administered3 reports
stomatitis3 reports
bacterial infection2 reports
burkholderia test positive2 reports
choking2 reports
dysgeusia2 reports
nausea2 reports
tongue discomfort2 reports
arthralgia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Dosage & Administration

Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 ml (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

Warnings

The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS.

Contraindications

Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Adverse Reactions

The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with 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 been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) r…

Frequently Asked Questions

What is Acclean Chlorhexidine Gluconate 0.12% Oral Rinse used for?

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse contains Chlorhexidine Gluconate 0.12% Oral Rinse. It is a liquid taken oral. Consult your doctor for specific uses.

Is Acclean Chlorhexidine Gluconate 0.12% Oral Rinse a controlled substance?

Acclean Chlorhexidine Gluconate 0.12% Oral Rinse is not classified as a controlled substance by the DEA.

What is the generic name for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?

The generic name for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse is Chlorhexidine Gluconate 0.12% Oral Rinse. There are 6 other brand versions of Chlorhexidine Gluconate 0.12% Oral Rinse.

What is the NDC code for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL?

The NDC (National Drug Code) for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL is 0116-4075, listed by Xttrium Laboratories, Inc..

Product NDC

0116-4075

Package NDC

0116-4075-01

Other Chlorhexidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)