Label: TOTAL ADVANCED HEALTH FRESH MINT- cetylpyridinium chloride rinse
- NDC Code(s): 35000-390-12, 35000-390-27, 35000-390-68
- Packager: Colgate-Palmolive Company
- 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 December 5, 2019
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- PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TOTAL ADVANCED HEALTH FRESH MINT
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-390 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER OIL (UNII: 3W1JG795YI) BETA CAROTENE (UNII: 01YAE03M7J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-390-68 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2017 2 NDC:35000-390-12 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2017 3 NDC:35000-390-27 800 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 01/09/2017 Labeler - Colgate-Palmolive Company (001344381)