Label: AIM BUBBLE BERRY- sodium fluoride gel, dentifrice

  • NDC Code(s): 10237-625-44, 10237-625-48
  • Packager: Church & Dwight Co., Inc.
  • 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 18, 2023

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  • ACTIVE INGREDIENT

    Active ingredients 
    Sodium fluoride (0.24%)

  • PURPOSE

    Purpose
    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use  aids in the prevention of dental decay

  • KEEP OUT OF REACH OF CHILDREN

    Warnings
    Keep out of reach of children under 6 years of age    .

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions    do not swallow    supervise children as necessary until capable of using without supervision

    adults and children 2 years and older               brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
    children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)
    children under 2 years                                    ask a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients  sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, cellulose gum, sodium saccharin, blue 1, mica, titanium dioxide.

  • QUESTIONS

    Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET

  • Principal Display Panel - AIM Kids

    TAKE AIM AGAINST CAVITIES





    AIM kids



    MEGA Bubble Berry

    NET WT. 4.4 OZ. (136g)

    Cleans and Protects Tastes Great Helps Prevent Cavities







    Anticavity Fluoride



    Gel Toothpaste

    Alcohol Free

    R3_Kids_PA1082265_R5lr

  • INGREDIENTS AND APPEARANCE
    AIM  BUBBLE BERRY
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-625
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBERRY (Bubble Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-625-481 in 1 CARTON10/01/201009/24/2019
    1136 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-625-441 in 1 CARTON09/24/2019
    2125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2008
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-625)
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