Label: COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF- sodium fluoride paste, dentifrice
- NDC Code(s): 35000-998-60, 35000-998-71
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 4, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician - Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-998 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 191.18 mg in 1 g HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PHOSPHORIC ACID (UNII: E4GA8884NN) BENZYL ALCOHOL (UNII: LKG8494WBH) 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:35000-998-71 1 in 1 CARTON 11/01/2022 1 119 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-998-60 1 in 1 CARTON 11/01/2022 2 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 11/01/2022 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Mission Hills, S.A. de C.V. 812312122 ANALYSIS(35000-998) , MANUFACTURE(35000-998) , PACK(35000-998) , LABEL(35000-998)