PURE SNOW WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ITENA CLINICAL]

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PURE SNOW WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ITENA CLINICAL]
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NDC 52893-001-01
Set ID 39c23d08-79f4-4047-a502-a34fbd92d381
Category HUMAN OTC DRUG LABEL
Packager Itena Clinical
Generic Name
Product Class
Product Number
Application Number PART355
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  • 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)
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