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koala pals (Melaleuca, Inc.)

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PASTE, DENTIFRICE 108 g in 1 TUBE (54473-204-04) Label Information

Complete koala pals Information

  • ACTIVE INGREDIENT

    Active ingredient
    Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)


  • PURPOSE

    Purpose
    Anticavity


  • INDICATIONS & USAGE

    Use aids in the prevention of cavities


  • KEEP OUT OF REACH OF CHILDREN

    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 right away.


  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: 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: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    • children under 2 years of age: ask a dentist or doctor

  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol


  • WARNINGS

    Warnings


  • INGREDIENTS AND APPEARANCE
    KOALA PALS  BERRYLICIOUS
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-204
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2592 g  in 108 g
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-204-04 108 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 04/01/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    Name Address ID/FEI Business Operations
    Melaleuca, Inc._Knoxville 805617610 manufacture