Label: PLAK SMACKER- sodium fluoride paste, dentifrice 

  • Label RSS
  • NDC Code(s): 55346-0718-1, 55346-0718-2
  • Packager: Dental Technologies, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Sodium Fluoride 0.24%

    (0.14% w/v fluoride ion)

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  • Purpose

    Anticavity toothpaste

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  • Uses

    Helps aid in the prevention of dental cavities.

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  • Warnings

    Do not use if inner foil is torn, cut or missing.

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

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

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  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
    • Do not swallow
    • To minimum swallowing use a pea sized amount in children under 6
    • Instruct children under 6 years of age in good brushing and rinsing habits
    • Supervise children as necessary until capable of using without supervision
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  • Inactive Ingredients

    Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

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  • Questions or comments?

    1-800-558-6684

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  • SPL UNCLASSIFIED SECTION

    "The ADA Council on Scientific Affairs'

    Acceptance of Plak Smacker® Great White

    Shark Fluoride Gel Toothpaste is based on

    its finding that the product is effective in

    helping to prevent and reduce tooth decay,

    when used as directed."

    Distributed by: PLAK SMACKER® 00181

    Corona, CA 92879                         REV1

    (800) 558-6684 www.plaksmacker.com

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  • Principal Display Panel

    PLAK SMACKER®

    GREAT WHITE

    SHARK

    NO

    SUGAR

    ADDED

    ADA

    ACCEPTED

    American Dental Association

    COOL BERRY FLAVOR

    ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

    NET WT. 4.2 OZ (120G)

    image description

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  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55346-0718
    Route of Administration DENTAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL  
    WATER  
    HYDRATED SILICA  
    POLYETHYLENE GLYCOL 300  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM LAURYL SULFATE  
    POLYETHYLENE GLYCOL 1450  
    SACCHARIN SODIUM  
    METHYLPARABEN  
    PROPYLPARABEN  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BERRY (Cool Berry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55346-0718-2 120 g in 1 TUBE
    2 NDC:55346-0718-1 24 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 12/31/2007
    Labeler - Dental Technologies, Inc (148312838)
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