PURE SNOW WHITENING- sodium fluoride gel, dentifrice

Pure Snow whitening by

Drug Labeling and Warnings

Pure Snow whitening by is a Otc medication manufactured, distributed, or labeled by Itena Clinical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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)

INGREDIENTS AND APPEARANCE

PURE SNOW WHITENING 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52893-001
Route of Administration	DENTAL

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)