Label: COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA- sodium fluoride paste, dentifrice
- NDC Code(s): 65954-810-42, 65954-810-60, 65954-810-63
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 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 physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-810 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-810-60 1 in 1 CARTON 01/01/2023 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:65954-810-42 1 in 1 CARTON 01/01/2023 2 119 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:65954-810-63 1 in 1 CARTON 05/28/2024 3 85 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 OTC MONOGRAPH DRUG M021 01/01/2023 Labeler - Colgate-Palmolive Company (812312122) Registrant - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Mission Hills, S.A. de C.V. 812312122 ANALYSIS(65954-810) , MANUFACTURE(65954-810) , PACK(65954-810) , LABEL(65954-810)