Label: MEDICHOICE PREMIUM ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • MediChoice Premium Anticavity Fluoride Toothpaste

    Drug Facts

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Anticavity

  • USE

    Aids in the prevention of dental cavities

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children under 6 years of age.

  • DIRECTIONS

    • Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or a doctor.
  • INACTIVE INGREDIENTS

    sorbitol, silica, water, glycerin, polythelene glycol 1500, sodium lauryl sulfate, flavor, titanium dioxide, cellulose gum, carrageenan, trisodium orthophosphate, sodium saccharin, sodium benzoate, tetrasodium pyrophosphate, methylparaben, propylparaben, FD & C blue #1

    Made in India, Distributed by Owens & Minor, 9120 Lockwood Boulevard, Mechanicsville, VA 23116

    C.No. DNH/COS/DNH/52Exp. Date & Lot No. on Crimp Rev. A

  • MediChoice Premium Anticavity Fluoride Toothpaste 24g (39892-0603-2)

    Medichoice0603
  • INGREDIENTS AND APPEARANCE
    MEDICHOICE PREMIUM ANTICAVITY FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0603
    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)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0603-224 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/01/2013
    Labeler - Owens & Minor (847412269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650599231manufacture(39892-0603)
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