Label: COLGATE JUNIOR BUBBLE FRUIT- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-327-20, 65954-327-46, 65954-327-59
  • 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 November 10, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

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

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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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
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  • 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

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  • Questions?

    1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 76 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    Kids
    Cavity
    Protection
    Bubble Fruit® Flavor

    Fights Cavities
    Clinically Proven
    Enamel Safe

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 2.7 OZ (76 g)

    PRINCIPAL DISPLAY PANEL - 76 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    COLGATE JUNIOR BUBBLE FRUIT 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-327
    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) 476 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor FRUIT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-327-59 1 in 1 CARTON 11/11/2016
    1 76 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:65954-327-20 1 in 1 CARTON 11/11/2016
    2 24 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:65954-327-46 1 in 1 CARTON 11/11/2016
    3 130 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 11/11/2016
    Labeler - Mission Hills S.A de C.V (812312122)
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