BURST WONDERFULLY WHITENING ANTI CAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [BURST.USA.INC]

BURST WONDERFULLY WHITENING ANTI CAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [BURST.USA.INC]
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NDC 71275-001-47
Set ID 48c22ca2-1238-6d6e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager BURST.USA.Inc
Generic Name
Product Class
Product Number
Application Number PART355
  • Active Ingredient

    Sodium fluoride 0.243%

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • Keep out of the reach of children

    under 6 years of age.

  • Warnings

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

  • Inactive ingredients

    benzyl alcohol, cellulose gum, flavor, glycerin, PEG-32, propylene glycol, PVM/MA copolymer, silica, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    BURST  WONDERFULLY WHITENING ANTI CAVITY
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71275-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71275-001-47133 g in 1 TUBE; Type 0: Not a Combination Product02/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/20/2017
    Labeler - BURST.USA.Inc (080474113)

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