Label: NATURE MINT ANTICAVITY- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 August 13, 2019

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate - 0.76% (Total Fluoride Content - 1000 ppm Approx.)

    DRUG FACTS

  • PURPOSE

    Anticavity.

  • USE

    Helps protect against cavities.

  • WARNINGS

    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 immediately.

    INACTIVE INGREDIENTS

    Calcium Carbonate, Purified Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Glycerin, Sodium Carboxy Methyl Cellulose, Flavor, Sodium Saccharin, Sodium Benzoate.

  • DIRECTIONS:

    Adults & Children 6 years of age & older : Brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    Children 2 to 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 physician.

  • PRINCIPAL DISPLAY PANEL - 43 g Tube

    display panel

  • INGREDIENTS AND APPEARANCE
    NATURE MINT ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76001-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76001-001-017.94 g in 1 PACKET; Type 0: Not a Combination Product01/01/2018
    2NDC:76001-001-0217 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    3NDC:76001-001-0324 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    4NDC:76001-001-0443 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    5NDC:76001-001-0578 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    6NDC:76001-001-071 in 1 CARTON01/01/2018
    6181 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:76001-001-061 in 1 CARTON01/01/2018
    7130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2018
    Labeler - Daxal Cosmetics Private Limited (650497790)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daxal Cosmetics Private Limited650497790manufacture(76001-001)
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