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Whitening (Melaleuca, Inc.)

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PASTE 108 g in 1 TUBE (54473-188-04) Label Information

Complete Whitening Information

  • ACTIVE INGREDIENT

    Active ingredient
    Sodium Fluoride (0.243%)


  • PURPOSE

    Purpose
    Anticavity


  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities


  • WARNINGS

    Warnings


  • KEEP OUT OF REACH OF CHILDREN

    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. Warning: This product contains propolis, which can cause allergic reactions.


  • 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 physician
    • instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    • children under 2 years of age: consult a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol


  • INGREDIENTS AND APPEARANCE
    WHITENING  TOOTH POLISH
    sodium fluoride paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-188
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.26244 g  in 108 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MYRRH OIL (UNII: H74221J5J4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PAPAIN (UNII: A236A06Y32)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (Cool Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-188-04 108 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