Label: MINTBLAST- sodium fluoride paste

  • NDC Code(s): 72326-8001-1
  • Packager: YOUNG PS ACQUISITION, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 23, 2021

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  • Active ingredient

    Sodium Fluoride -0.243 mg (0.15% w/v Fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of cavities.

  • Directions : 

    • Adults and children 2 years of age  and  older: Brush teeth thoroughly, preferably after each  meal or at least twice a day,  or use as directed by a dentist or a physician.
    • Children  2 to  6  years: Use only a  pea sized amount and supervise child's brushing and rinsing  (to minimize swallowing) .
    • Children under 2 year : Ask a dentist or physician .
  • Warnings 

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

  • WARNINGS

  • Inactive Ingredients

     Sorbitol, Silica , Treated Water , Poly Ethylene Glycol 1500 , Sodium Lauryl Sulfate , Flavor,  Titanium Dioxide , Cellulose Gum and/or Carrageenan, Tri Sodium Ortho Phosphate,   Saccharin Sodium, Tetra Sodium Pyrophosphate,Glycerine,  Color : FD&C Blue No.1

  • Mint Blast Product  Label 

    image description

  • INGREDIENTS AND APPEARANCE
    MINTBLAST 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72326-8001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72326-8001-128 g in 1 TUBE; Type 0: Not a Combination Product05/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/26/2018
    Labeler - YOUNG PS ACQUISITION, LLC (119620784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650599231manufacture(72326-8001)
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