Label: COLGATE TOTAL WHITENING- sodium fluoride and triclosan paste, dentifrice
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NDC Code(s):
35000-002-34,
35000-002-42,
35000-002-60,
35000-002-71, view more35000-002-78
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 11, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
supervise children as necessary until capable of using without supervision.
adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician children under 12 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 6 years do not use unless directed by a dentist or a physician Antiplaque and antigingivitis use not proven in children.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE TOTAL WHITENING
sodium fluoride and triclosan paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARRAGEENAN (UNII: 5C69YCD2YJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE, WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-002-42 1 in 1 CARTON 09/20/2010 01/01/2022 1 119 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-002-34 2 in 1 CARTON 09/20/2010 01/01/2022 2 170 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-002-60 1 in 1 CARTON 09/20/2010 01/01/2022 3 170 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:35000-002-71 1 in 1 CARTON 09/20/2010 02/23/2011 4 204 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:35000-002-78 1 in 1 CARTON 09/20/2010 01/01/2022 5 221 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020231 09/20/2010 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive 785047999 MANUFACTURE(35000-002)