Label: PLAK SMACKER GREAT WHITE SHARK- sodium fluoride paste

  • NDC Code(s): 72326-8003-1, 72326-8003-2, 72326-8003-3
  • Packager: YOUNG PS ACQUISITION, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2023

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  • Active Ingredient

    Sodium Fluoride 0.24%

    (0.14% w/v Fluoride ion)

    Purpose

    Anticavity toothpaste

  • Purpose

    Anti-Cavity

    Toothpaste

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

    Keep out of the 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.

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

  • Warnings

    Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

  • DO NOT USE

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

  • 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 physician.
    • Do not swallow.
    • To minimize swallowing use a pea sized amount in children under 6 years.
    • Supervise children's brushing until good habits are established.
    • Children under 2 years of age, consult a dentist or physician.
  • Inactive Ingredients

    Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue1

  • Questions or comments?

    (800) 558-6684

  • PRINCIPAL DISPLAY PANEL

    PLAK SMACKER®

    GREAT WHITE SHARK

    NO SUGAR ADDED

    COOL BERRY FLAVOR

    ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

    NET WT. 4.2oz (119g)

    Shark_image.jpg

    Shark_small_image.jpg

  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER GREAT WHITE SHARK 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72326-8003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    RASPBERRY (UNII: 4N14V5R27W)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72326-8003-1120 g in 1 TUBE; Type 0: Not a Combination Product07/19/2023
    2NDC:72326-8003-224 g in 1 TUBE; Type 0: Not a Combination Product07/19/2023
    3NDC:72326-8003-324 g in 1 TUBE; Type 0: Not a Combination Product07/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/27/2018
    Labeler - YOUNG PS ACQUISITION, LLC (119620784)
    Registrant - YOUNG PS ACQUISITION, LLC (119620784)
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