Pure Snow Whitening
FDA Label NDC 52893-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Itena Clinical for the product Pure Snow Whitening (NDC 52893-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 28.35 g tube label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured For:
ITENA CLINICAL
www.itena-clinical.com
83 Avenue Foch
75116 Paris France

Active Ingredients

Contains: Sodium Fluoride 0.25%w/w

Purpose

Anticavity

Use

Aids in the prevention of dental decay.

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (28.35 g Tube Label)

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