Label: COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH- cetylpyridinium chloride rinse
- NDC Code(s): 35000-723-02, 35000-723-16, 35000-723-33, 35000-723-84
- 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 February 17, 2022
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PRINCIPAL DISPLAY PANEL - 1L Bottle Label
ALCOHOL FREE
Colgate®
Antigingivitis Antiplaque MouthwashTotal
WHOLE MOUTH HEALTHGUM HEALTH
HELPS FIGHT PLAQUE & GINGIVITISANTIBACTERIAL
45% Stronger, Healthier Gums*Fights Plaque Between Teeth &
Along the Gum LineHelps Prevent Gingivitis
10X LONGER LASTING COOL**
CLEAN MINT
33.8 FL OZ (1.05 QT) 1L
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INGREDIENTS AND APPEARANCE
COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-723 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) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-723-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 2 NDC:35000-723-33 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 3 NDC:35000-723-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 4 NDC:35000-723-84 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 03/01/2015 Labeler - Colgate-Palmolive Company (001344381)