Label: BURST WONDERFULLY WHITENING ANTI CAVITY- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!