Label: PURE SNOW WHITENING- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 November 29, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Contains: Sodium Fluoride 0.25%w/w

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental decay.

  • 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.

  • 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.
    • Instruct children under 6 years of age in 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 doctor.
  • Inactive Ingredients

    Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No.1 (CI 42090), FD&C Yellow No.5 (CI 19140), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, Xanthan Gum

  • SPL UNCLASSIFIED SECTION

    Manufactured For:
    ITENA CLINICAL
    www.itena-clinical.com
    83 Avenue Foch
    75116 Paris France

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Label

    PURE
    SNOW

    with Fluoride

    whitening toothpaste

    NET WT 1.0 OZ (28.35g)

    Principal Display Panel - 28.35 g Tube Label
  • INGREDIENTS AND APPEARANCE
    PURE SNOW WHITENING 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52893-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.07 g  in 28.35 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sorbitol (UNII: 506T60A25R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52893-001-0128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/30/2012
    Labeler - Itena Clinical (262150858)
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

More Info on this Drug

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