Label: COLGATE ZERO CLEAR SPEARMINT- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 23, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 years of age.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    Sorbitol, Water, Hydrated Silica, Xylitol, PEG-12, Cellulose Gum, Flavor, Sodium Lauryl Sulfate, Benzyl Alcohol, Rebaudioside A.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

    NEW

    Colgate®
    Anticavity Fluoride Toothpaste

    zero
    0% ARTIFICIAL
    FLAVORS • SWEETENERS
    PRESERVATIVES • COLORS

    CLEAR GEL
    SPEARMINT

    NET WT
    4.6 OZ (130g)

    STRENGTHENS ENAMEL AND PROVIDES CLINICALLY PROVEN CAVITY PROTECTION

    PRINCIPAL DISPLAY PANEL - 130 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE ZERO CLEAR SPEARMINT 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-789
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R) 680 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    ColorWHITE (Transparent slightly beige) Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-789-461 in 1 CARTON10/02/2019
    1130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35510/02/2019
    Labeler - Mission Hills S.A de C.V (812312122)
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