Label: PLAK SMACKER- stannous fluoride gel

  • 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 October 1, 2015

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  • Active Ingredient

    Stannous Fluoride 0.4%

  • Purpose

    Anticavity

  • Uses

    Helps aid in the prevention of dental cavities.

  • Warnings:

    This is an anticavity fluoride preventive treatment gel, not a toothpaste.

    Read directions carefully before using.

    When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.

  • 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.

  • Directions:

    • Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
    • Instruct children under 12 years of age in the use of this product (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

    Do not use if the foil seal under the cap is torn, cut or missing.

  • Inactive Ingredients:

    Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

  • Questions or comments?

    1-800-558-6684

  • Principal Display Panel

    HOME CARE

    FLUORIDE GEL

    0.4% STANNOUS FLUORIDE

    Groovy Grape

    11426

    AIDS IN THE

    PREVENTION

    OF DENTAL CAVITIES

    PLAK SMACKER

    Net Weight 4.3 oz. (121.9g)

    grape tube

  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER 
    stannous fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-0418
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.969 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Groovy Grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55346-0418-2121.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/31/2007
    Labeler - Dental Technologies, Inc. (148312838)
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