Label: DISCOUNT DRUG MART MINT MOUTHWASH- cetylpyridinium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53943-553-34 - Packager: DISCOUNT DRUG MART
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 7, 2014
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- ACTIVE INGREDIENT
- USES
- WARNINGS
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DIRECTIONS
USE AFTER YOUR NORMAL BRUSHING AND FLOSSING ROUTINE; RINSE TOOTHPASTE FROM MOUTH PRIOR TO USE. ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE FOR 30 SECONDS WITH 20 ML (4 TEASPOONFULS) TWICE A DAY. DO NOT SWALLOW. CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE: SUPERVISE USE. CHILDREN UNDER 6 YEARS OF AGE: DO NOT USE.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- LABEL COPY
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INGREDIENTS AND APPEARANCE
DISCOUNT DRUG MART MINT MOUTHWASH
cetylpyridinium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-553 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 407 (UNII: TUF2IVW3M2) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-553-34 1000 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/06/2014 Labeler - DISCOUNT DRUG MART (047741335) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(53943-553)