Label: ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM- sodium fluoride rinse

  • 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 August 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Sodium fluoride 0.05% (Fluoride ion-0.0226%)

  • PURPOSE

    Purpose

    Anticavity rinse

  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities.

  • WARNINGS

    Warning

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

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
    • remove cap
    • use approximately one tablespoon and rinse vigorously 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
    • supervise children as necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature
  • SPL UNCLASSIFIED SECTION

    *Anticavity Fluoride Rinse is not manufactured or distributed by Personal Products Company division or McNeil-PPC., distributor or Act®

    DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

    CHESAPEAKE, VA 23320

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    ASSURED™

    Compare to ACT® active ingredient*

    Kids Anticavity

    Fluoride Rinse
    BUBBLEGUM

    ALCOHOL FREE

    CAVITY PROTECTION
    18 FL. OZ. (532 mL)

    Kids Anticavity Fluoride Rinse

  • INGREDIENTS AND APPEARANCE
    ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0015-7532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2010
    Labeler - Greenbrier International, Inc. (610322518)
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