Label: COLGATE KIDS TROLLS ALCOHOL FREE ANTI-CAVITY SPARKLE TIME BUBBLE FRUIT- sodium fluoride rinse

  • NDC Code(s): 35000-383-16, 35000-383-84
  • 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 January 25, 2023

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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

  • Other information

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

  • 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, D&C red no. 33, FD&C green no. 3

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

    NEW

    ALCOHOL FREE
    Colgate®

    Anticavity Fluoride Rinse

    Kids

    DREAMWORKS
    Trolls

    ✅
    Strengthens
    Enamel
    ✅
    Protects from
    Cavities
    ✅
    Cleans the
    Whole Mouth*

    P9913559

    8.4 FL OZ
    (250mL)

    Sparkle Time™ Bubble Fruit®
    IMPORTANT: Read directions for proper use

    PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE KIDS TROLLS ALCOHOL FREE ANTI-CAVITY SPARKLE TIME BUBBLE FRUIT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-383
    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)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-383-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/201912/30/2024
    2NDC:35000-383-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/201612/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35508/05/201612/30/2024
    Labeler - Colgate-Palmolive Company (001344381)
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