Label: COLGATE OPTIC WHITE PROSERIES VIVIDLY FRESH- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 35000-749-30
- 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 October 31, 2019
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- Official Label (Printer Friendly)
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE PROSERIES VIVIDLY FRESH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-749 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 POLOXAMER 105 (UNII: XPP85ZHV76) 450 mg in 1 g CROSPOVIDONE (UNII: 2S7830E561) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) 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:35000-749-30 1 in 1 CARTON 11/25/2021 1 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 FINAL part355 11/23/2021 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Mission Hills, S.A. de C.V. 812312122 ANALYSIS(35000-749) , MANUFACTURE(35000-749) , PACK(35000-749) , LABEL(35000-749)