Drugplain

DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL

Chlorhexidine Gluconate 0.12% Oral Rinse · LIQUID · Cardinal Health 107, LLC

No Recall History
Plain English

DASH 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 Cardinal Health 107, LLC.

Key Facts

Brand Name
DASH Chlorhexidine Gluconate 0.12% Oral Rinse
Generic Name
Chlorhexidine Gluconate 0.12% Oral Rinse
NDC Code (Product)
55154-1981
Manufacturer
Cardinal Health 107, LLC
Strength
1.2 mg/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
ANDA074291
Marketing Start
04/25/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

recalled product administered3 reports
bacterial infection2 reports
burkholderia test positive2 reports
choking2 reports
oral discomfort2 reports
stomatitis2 reports
tongue discomfort2 reports
application site swelling1 reports
arthralgia1 reports
burning mouth syndrome1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND 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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .

Dosage & Administration

DOSAGE AND ADMINISTRATION Chlorhexidine Gluconate Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15ml (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

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

CONTRAINDICATIONS: This product should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Adverse Reactions

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 1.0%. Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate 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 (sial…

Frequently Asked Questions

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

DASH 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 DASH Chlorhexidine Gluconate 0.12% Oral Rinse a controlled substance?

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

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

The generic name for DASH Chlorhexidine Gluconate 0.12% Oral Rinse is Chlorhexidine Gluconate 0.12% Oral Rinse. There are 7 other brand versions of Chlorhexidine Gluconate 0.12% Oral Rinse.

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

The NDC (National Drug Code) for DASH Chlorhexidine Gluconate 0.12% Oral Rinse 1.2 mg/mL is 55154-1981, listed by Cardinal Health 107, LLC.

Product NDC

55154-1981

Package NDC

55154-1981-5

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)