DailyMed Label: DASH Chlorhexidine Gluconate 0.12% Oral Rinse

DailyMed Label: DASH Chlorhexidine Gluconate 0.12% Oral Rinse

2023

DailyMed Prescription

DASH Chlorhexidine Gluconate 0.12% Oral Rinse

Chlorhexidine Gluconate 0.12% Oral Rinse

Natco Pharma USA LLC

NDC: 69339-138

NDC: 69339-138

NDC: 69339-138

This product is an oral rinse containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-0-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint oil, saccharin sodium, and FD&C Blue #1. The pH may be adjusted with hydrochloric acid or sodium hydroxide. The solution is near-neutral (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its molecular formula is C 22 H 30 Cl 2 N 10 •2C 6 H 12 0 7 , molecular weight 897.77 and its structural formula is: chemical structure

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 .

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.

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

General: 1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate should not be used as a major indicator of underlying periodontitis. 2. Chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of chlorhexidine gluconate oral rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations. 3. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following use of chlorhexidine gluconate oral rinse have been reported via postmarketing product surveillance.

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

Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes: 1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups. 1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack. 1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in original container or in amber glass bottles.

Chlorhexidine gluconate provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use. Use of chlorhexidine gluconate oral rinse in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

UNIT DOSE Delivers 15mL NDC 69339-138-15 Chlorhexidine Gluconate Oral Rinse USP 0.12% N3 69339 13815 Rx only Manufactured for: DASH Pharmaceuticals LLC Upper Saddle River, NJ 07458 R0-09/17 Product Label