Label: COLGATE TOTAL ULTRA FRESH- cetylpyridinium chloride rinse
- NDC Code(s): 35000-735-33
- 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 January 12, 2022
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PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
ALCOHOL FREE
Colgate®
Antigingivitis Antiplaque MouthwashTotal
WHOLE MOUTH HEALTHULTRA FRESH
PROVIDES AN INSTANT AND
LONG-LASTING FRESH FEELINGCETYLPYRIDINIUM CHLORIDE MOUTHWASH
ANTIBACTERIAL
Kills 99% of Bacteria
Significantly Reduces Plaque
Helps Prevent Gingivitis10X LONGER LASTING COOL*
PEPPERMINT • CHARCOAL
33.8 FL OZ (1.05 QT) 1L
PS0028155
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INGREDIENTS AND APPEARANCE
COLGATE TOTAL ULTRA FRESH
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-735 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 15 mg in 20 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color BLACK Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-735-33 1 L in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 01/01/2022 Labeler - Colgate-Palmolive Company (001344381)