Label: COLGATE JUNIOR MIXED KIDS BUBBLE FRUIT FLUORIDE- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-958-46
  • 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 July 19, 2021

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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, Blue 1, Yellow 10.

  • 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 - Fire Truck

    Colgate®
    Anticavity Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 4.6 OZ (130 g)

    Kids
    Cavity
    Protection
    Bubble Fruit®

    TURN this
    CARTON
    into a
    FIRE TRUCK

    Fights
    Cavities

    Clinically
    Proven

    Enamel
    Safe

    Principal Display Panel - 130 g Tube Carton - Fire Truck
  • PRINCIPAL DISPLAY PANEL - 130 g Tube Carton - Princess Carriage

    Colgate®
    Anticavity Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 4.6 OZ (130 g)

    Kids
    Cavity
    Protection
    Bubble Fruit®

    Turn this
    Carton
    into a Princess
    Carriage

    Fights
    Cavities

    Clinically
    Proven

    Enamel
    Safe

    Principal Display Panel - 130 g Tube Carton - Princess Carriage
  • INGREDIENTS AND APPEARANCE
    COLGATE JUNIOR MIXED KIDS BUBBLE FRUIT FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-958
    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:35000-958-46130 g in 1 TUBE; Type 0: Not a Combination Product12/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/26/2017
    Labeler - Colgate-Palmolive Company (001344381)
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