Label: COLGATE OPTIC WHITE BEAUTY RADIANT- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 65954-385-16, 65954-385-63 - Packager: Mission Hills S.A de C.V
- 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 13, 2016
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- adults and children 6 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 6 to 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
- children under 6 years: do not use unless directed by a dentist or physician
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Label
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE BEAUTY RADIANT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-385 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 392.5 mg in 1 g CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) POVIDONE K15 (UNII: E54VE15114) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ZINC OXIDE (UNII: SOI2LOH54Z) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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:65954-385-63 85 g in 1 TUBE; Type 0: Not a Combination Product 10/17/2016 2 NDC:65954-385-16 1 in 1 CARTON 10/17/2016 2 21.2 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 10/17/2016 Labeler - Mission Hills S.A de C.V (812312122)
