Label: COLGATE OPTIC WHITE SPARKLING MINT FLAVOR- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 67659-330-04 - Packager: Team Technologies, Inc
- This is a repackaged label.
- Source NDC Code(s): 65954-771
- 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 May 20, 2016
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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 - 141 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE SPARKLING MINT FLAVOR
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-330(NDC:65954-771) 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) 341.6 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) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) 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:67659-330-04 178 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 05/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/18/2013 Labeler - Team Technologies, Inc (192339703) Registrant - Team Technologies, Inc (192339703) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079337800 relabel(67659-330) , repack(67659-330)