PURE SNOW WHITENING- sodium fluoride gel, dentifrice 
Itena Clinical

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.

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Pure Snow whitening toothpaste

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

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

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
PURE SNOW WHITENING 
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52893-001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 0.07 g  in 28.35 g
Inactive Ingredients
Ingredient Name Strength
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
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)

Revised: 11/2012
Document Id: 01e0d895-cc73-46b3-a9cd-14550957c5ca
Set id: 39c23d08-79f4-4047-a502-a34fbd92d381
Version: 1
Effective Time: 20121129
 
Itena Clinical