Label: COLGATE KIDS MINIONS MOUTHWASH- sodium fluoride rinse

  • NDC Code(s): 35000-727-16, 35000-727-84
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

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

  • Directions

    Adults and children 6 years of age and older:

    • use twice a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision

    Children under 6 years of age: consult a dentist or doctor

  • Inactive ingredients

    water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1

  • Other Information

    Store at controlled room temperature 68 – 77° F (20 – 25°C)

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    NEW

    ALCOHOL FREE

    Colgate®

    Kids Anticavity Fluoride Rinse

    ILLUMINATION
    ENTERTAINMENT

    minions™

    16.9 FL OZ
    (1.05 PT) 500 mL

    P9902670

    BELLO™ BUBBLE FRUIT®

    IMPORTANT: Read directions for proper use

    Principal Display Panel - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE KIDS MINIONS MOUTHWASH 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-727
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-727-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
    2NDC:35000-727-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02108/01/2015
    Labeler - Colgate-Palmolive Company (001344381)
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