Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL
Chlorhexidine Gluconate Oral Rinse · SOLUTION · NuCare Pharmaceuticals,Inc.
Chlorhexidine Gluconate Oral Rinse is a solution containing chlorhexidine gluconate oral rinse at 1.2 mg/mL, taken dental. Manufactured by NuCare Pharmaceuticals,Inc..
Key Facts
- Brand Name
- Chlorhexidine Gluconate Oral Rinse
- Generic Name
- Chlorhexidine Gluconate Oral Rinse
- NDC Code (Product)
68071-3630- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 1.2 mg/mL
- Dosage Form
- SOLUTION
- Route
- DENTAL
- Marketing Status
- Application #
- ANDA075561
- Marketing Start
- 07/27/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATION 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
DOSAGE AND 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 oral rinsing for 30 seconds, morning and evening after toothbrushing. 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
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 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
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 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 (…
Frequently Asked Questions
What is Chlorhexidine Gluconate Oral Rinse used for?
Chlorhexidine Gluconate Oral Rinse contains Chlorhexidine Gluconate Oral Rinse. It is a solution taken dental. Consult your doctor for specific uses.
Is Chlorhexidine Gluconate Oral Rinse a controlled substance?
Chlorhexidine Gluconate Oral Rinse is not classified as a controlled substance by the DEA.
What is the generic name for Chlorhexidine Gluconate Oral Rinse?
The generic name for Chlorhexidine Gluconate Oral Rinse is Chlorhexidine Gluconate Oral Rinse. There are no other listed brand versions of Chlorhexidine Gluconate Oral Rinse.
What is the NDC code for Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL?
The NDC (National Drug Code) for Chlorhexidine Gluconate Oral Rinse 1.2 mg/mL is 68071-3630, listed by NuCare Pharmaceuticals,Inc..
Other Chlorhexidine Gluconate Oral Rinse Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)