Label: AIM CAVITY PROTECTION WITH WHITENING- sodium fluoride gel, dentifrice

  • NDC Code(s): 10237-637-55, 10237-637-60
  • 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-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, titanium dioxide, red 33, red 40

  • QUESTIONS

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

  • Principal Display Panel

    TAKE AIM AGAINST CAVITIES

    AIM Cavity Protection

    With Whitening

    CinnaMint Gel

    NET WT. 6.0 OZ. (170g)

    Anticavity Fluoride Gel Toothpaste

    MULTI-BENEFIT

    Cleans Freshens ProtectsAMFC-00065-01

  • INGREDIENTS AND APPEARANCE
    AIM  CAVITY PROTECTION WITH WHITENING
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-637
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCINNAMON (Cinnamint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-637-601 in 1 CARTON05/01/201209/26/2019
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-637-551 in 1 CARTON05/01/2019
    2156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/10/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-637)
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