Chlorhexidine gluconate rinse

Contraindications

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

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 serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS.

Precautions

Ingredients and appearance - Product information

Chlorhexidine gluconate rinse- Chlorhexidine gluconate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-685
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorhexidine gluconate ( UNII: MOR84MUD8E)( Chlorhexidine - UNII: R4KO0DY52L ) 1.2 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Glycerin ( UNII: PDC6A3C0OX)
Peg-40 sorbitan diisostearate ( UNII: JL4CCU7I1G)
Alcohol ( UNII: 3K9958V90M)
Saccharin sodium ( UNII: SB8ZUX40TY)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077789 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL( 63187-685)