Label: COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 65954-768-60, 65954-768-64, 65954-768-69, 65954-768-82
- Packager: Mission Hills S.A de C.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 29, 2019
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- 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 - 232 g Tube Label
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INGREDIENTS AND APPEARANCE
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-768 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 491.6 mg in 1 g HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CALCIUM PEROXIDE (UNII: 7FRO2ENO91) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN, WHITE Score Shape Size Flavor SPEARMINT, PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-768-69 1 in 1 CARTON 08/20/2011 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:65954-768-64 1 in 1 CARTON 08/20/2011 12/31/2017 2 181 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:65954-768-82 1 in 1 CARTON 08/20/2011 12/31/2017 3 232 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:65954-768-60 1 in 1 CARTON 08/20/2011 4 170 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 08/20/2011 Labeler - Mission Hills S.A de C.V (812312122) Establishment Name Address ID/FEI Business Operations Mission Hills, S.A. de C.V. 812312122 ANALYSIS(65954-768) , MANUFACTURE(65954-768) , PACK(65954-768) , LABEL(65954-768)