Label: AIM SENSITIVE CAVITY PROTECTION- potassium nitrate, sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 September 26, 2019

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  • ACTIVE INGREDIENT

    Active ingredients


    Potassium nitrate 5.0%
    Sodium fluoride 0.24%

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities

  • WARNINGS

    Warnings

    Do not use     for longer than 4 weeks unless recommended by a dentist or doctor

  • STOP USE

    Stop use and ask a dentist if the problem persists or worsens

    • Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older:

    • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • Brush teeth thoroughly for at least one minute, preferable after each meal or at least twice a day (morning and evening) or use as recommended by a dentist or physician.
    • Make sure to brush all sensitive areas of the teeth.

    Children under 12 years of age: consult a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

  • QUESTIONS

    Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com

  • Principal Display Panel

    Same Active Ingredient as Leading Sensitive Toothpaste

    TAKE AIM AGAINST CAVITIES

    AIM

    CAVITY PROTECTION

    Refreshing Mint

    Gel

    NET WT. 5.5OZ (156g)

    Anticavity Fluoride Gel Toothpaste

    SENSITIVE Cleans Freshens

    Protects Sensitive Teeth

    Carton image Carton image

  • INGREDIENTS AND APPEARANCE
    AIM SENSITIVE  CAVITY PROTECTION
    potassium nitrate, sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-632
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorMINT (Refreshing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-632-551 in 1 CARTON07/01/201507/19/2019
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/25/2015
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-632)
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