Label: COLGATE JUNIOR KIDS BATMAN MILD BUBBLE FRUIT FLUORIDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-585-46
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2018

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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, PEG-12, cellulose gum, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 130 g Tube Label

    Colgate®
    Anticavity Fluoride Toothpaste

    CLINICALLY PROVEN
    Cavity & Enamel Protection

    ADA
    ACCEPTED
    American
    Dental
    Association ®

    Toothpaste

    NET WT
    4.6 OZ
    (130 g)

    Mild BUBBLE FRUIT®

    PRINCIPAL DISPLAY PANEL - 130 g Tube Label
  • INGREDIENTS AND APPEARANCE
    COLGATE JUNIOR KIDS BATMAN MILD BUBBLE FRUIT FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-585
    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) 476 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-585-46130 g in 1 TUBE; Type 0: Not a Combination Product07/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02107/09/2018
    Labeler - Mission Hills S.A de C.V (812312122)
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