Label: PURE SNOW WHITENING- sodium fluoride gel, dentifrice

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

    Contains: Sodium Fluoride 0.25%w/w

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  • Purpose

    Anticavity

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  • Use

    Aids in the prevention of dental decay.

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  • 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.

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  • 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.
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  • 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

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    PURE SNOW WHITENING 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52893-001
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.07 g  in 28.35 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin  
    Water  
    Silicon Dioxide  
    Sorbitol  
    Xylitol  
    Methyl Salicylate  
    Poloxamer 407  
    Sodium Lauryl Sulfate  
    FD&C Blue No. 1  
    FD&C Yellow No. 5  
    Sodium Benzoate  
    Sodium Hydroxide  
    Sucralose  
    Xanthan Gum  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52893-001-01 28.35 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 11/30/2012
    Labeler - Itena Clinical (262150858)
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