WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.]

WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.]
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NDC 54473-188-04
Set ID d3270563-dd7e-474e-bae3-511efb430370
Category HUMAN OTC DRUG LABEL
Packager Melaleuca, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
  • 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

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    WHITENING  TOOTH POLISH
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.26244 g  in 108 g
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-188-04108 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc._Knoxville805617610manufacture

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