Label: PLAK SMACKER MINT BLAST- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 18, 2021

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  • Active Ingredients

    Sodium Fluoride 0.243% (equivalent to 0.13% w/v fluoride ion)

  • Purpose

    Anti-cavity

  • Uses

    Aids in the prevention of cavities

  • Warnings

    If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

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

  • 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 physician.

    Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.

    Children under 2 years: Ask a dentist or a physician.

  • Inactive Ingredients

    Sorbitol, Silica, Water, PEG-8, Sodium lauryl sulfate, Flavor, Titanium dioxide, Cellulose gum, Trisodium phosphate, Sodium saccharin, Xanthan gum, Benzyl alcohol, Xylitol, CI 42090

  • Principal Display Panel

    28 g NDC: 71775-080-01

    Mint Blast 28 g

  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER  MINT BLAST
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71775-080
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION130 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71775-080-0128 g in 1 TUBE; Type 0: Not a Combination Product03/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/18/2021
    Labeler - LMZ (654623156)
    Establishment
    NameAddressID/FEIBusiness Operations
    LMZ654623156manufacture(71775-080)
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