Your browser does not support JavaScript! PURE SNOW WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ITENA CLINICAL]
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PURE SNOW WHITENING (sodium fluoride) gel, dentifrice
[Itena Clinical]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52893-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.07 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
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)

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

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