Label: MINTBLAST ANTI CAVITY FLUORIDE- sodium fluoride paste

  • 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 January 6, 2018

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  • Active ingredients

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

    Purpose

    anticavity

  • Uses

    Aids in the prevention of cavities.

  • Warnings

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

    Keep out of reach of children.

  • Directions

    Adults and children 2years 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 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

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

  • INACTIVE INGREDIENT

    Glycerine,Sorbitol,Saccharin Sodium,Sodium benzoate,Sodium Carboxy Methyl Cellulose,Xanthan Gum,Sodium Fluoride,Treated Water,Silica,Sodium Lauryl Sulfate,Tianium Dioxide,Flavor,CI42090

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    MINTBLAST ANTI CAVITY FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-300
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71035-300-01144 in 1 BOX04/15/2016
    19.9 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71035-300-0272 in 1 BOX04/15/2016
    29.9 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71035-300-03144 in 1 BOX03/07/2016
    328.35 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:71035-300-0472 in 1 BOX03/07/2016
    428.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/11/2016
    Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-300)
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