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NATURES SMILE (Widepipe Corp)

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MOUTHWASH 250 mL in 1 BOTTLE, PLASTIC (76454-101-01) Label Information

Complete NATURES SMILE Information

  • ACTIVE INGREDIENT

    Active ingredients
    Sodium monofluorophosphate  (0.84%)


    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 right away.

    Purpose

    Mouthwash that aids in the prevention of dental cavities


    Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Inactive ingredients  water,sodium saccharin, sodium hydroxide,hydrogenated castor oil, triclosan.


        Adults and children 2 years and older:  brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor
        instruct children under 6 years   in good brushing and rinsing habits (to minimize swallowing)
        supervise children as necessary until capable of using without supervision
        children under 2 years ask a dentist or physician


    .

  • INGREDIENTS AND APPEARANCE
    NATURES SMILE 
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76454-101
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76454-101-01 250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 10/01/2011 10/01/2018
    Labeler - Widepipe Corp (029799329)
    Establishment
    Name Address ID/FEI Business Operations
    Widepipe Corp 029799329 manufacture, label