Label: COLGATE OPTIC WHITE HIGH IMPACT FLUORIDE- sodium monofluorophosphate paste, dentifrice
-
Contains inactivated NDC Code(s)
NDC Code(s): 67659-341-03 - Packager: Team Technologies, Inc
- This is a repackaged label.
- Source NDC Code(s): 65954-167
- 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 July 25, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
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
-
INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE HIGH IMPACT FLUORIDE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-341(NDC:65954-167) 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) 401 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) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) SUCRALOSE (UNII: 96K6UQ3ZD4) PHOSPHORIC ACID (UNII: E4GA8884NN) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) 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:67659-341-03 127 g in 1 TUBE; Type 0: Not a Combination Product 07/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/01/2015 Labeler - Team Technologies, Inc (192339703) Registrant - Team Technologies, Inc (192339703) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079337800 repack(67659-341) , relabel(67659-341)
