Label: PURE SNOW WHITENING- sodium fluoride gel, dentifrice
- NDC Code(s): 52893-001-01
- Packager: Itena Clinical
- 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.
Updated November 29, 2012
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
Contains: Sodium Fluoride 0.25%w/wClose
Aids in the prevention of dental decay.Close
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.
- 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 GumClose
- SPL UNCLASSIFIED SECTION
83 Avenue Foch
75116 Paris France
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Label
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 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)