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NATURES GUM BALM (Widepipe Corp)

Available Formats

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PASTE 75 g in 1 TUBE (76454-100-01) Label Information

Complete NATURES GUM BALM 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

    OTC toothpaste to clean teeth.


    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, sorbitol, glycerin. calcium pyrophosphate, hydrated silica, aluminum hydroxide, dicalcium phosphate, flavor, PEG-12, sodium lauryl sulfate, cellulose gum, trisodium phosphate, sodium phosphate, sodium saccharin, titanium dioxide

    Apply small amount to toothbrush and brush alone gum lines for 2 minutes total time.


        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 GUM BALM 
    sodium monofluorophosphate paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76454-100
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 8.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76454-100-01 75 g in 1 TUBE
    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 relabel, label