Label: COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 35000-952-86, 35000-952-93 - Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 12, 2019
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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 - 96 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-952 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 338.1 mg in 1 g CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POVIDONE K15 (UNII: E54VE15114) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:35000-952-93 1 in 1 CARTON 07/01/2015 1 96 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-952-86 1 in 1 CARTON 07/01/2015 2 127 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 FINAL part355 07/01/2015 Labeler - Colgate-Palmolive Company (001344381)
