Label: COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE- sodium monofluorophosphate paste, dentifrice
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NDC Code(s):
35000-978-14,
35000-978-16,
35000-978-32,
35000-978-44, view more35000-978-71, 35000-978-76, 35000-978-86
- 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 10, 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
- Questions?
- PRINCIPAL DISPLAY PANEL - 127 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-978 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) 401.3 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:35000-978-86 1 in 1 CARTON 10/14/2019 1 127 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-978-32 1 in 1 CARTON 10/14/2019 2 90 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-978-14 1 in 1 CARTON 10/14/2019 3 41 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:35000-978-16 1 in 1 CARTON 10/14/2019 4 21.2 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:35000-978-44 2 in 1 CARTON 10/14/2019 5 127 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:35000-978-76 2 in 1 CARTON 10/14/2019 6 90 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:35000-978-71 1 in 1 CARTON 11/26/2019 7 119 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 10/14/2019 Labeler - Colgate-Palmolive Company (001344381)
