Label: COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT- sodium fluoride gel, dentifrice
- NDC Code(s): 65954-041-81
- 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 April 10, 2019
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- Active ingredient
- Purpose
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- 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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- PRINCIPAL DISPLAY PANEL - 130 g Bottle Label
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INGREDIENTS AND APPEARANCE
COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-041 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) 665.075 mg in 1 g WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-041-81 130 g in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 07/26/2011 Labeler - Mission Hills S.A de C.V (812312122)