Label: EMMI-DENT WHITENING- sodium fluoride paste, dentifrice
- NDC Code(s): 63956-003-03
- Packager: EMAG AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warning
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Directions
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- adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist
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- do not swallow
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- to minimize swallowing use a pea-sized amount in children unter 6
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- supervise children's dental cleaning until good habits are established
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- children under 2 yrs.: ask a dentist
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
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INGREDIENTS AND APPEARANCE
EMMI-DENT WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63956-003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride 320 mg in 75 mL Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Hydrated Silica (UNII: Y6O7T4G8P9) Sodium Bicarbonate (UNII: 8MDF5V39QO) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) Titanium Dioxide (UNII: 15FIX9V2JP) Saccharin Sodium (UNII: SB8ZUX40TY) Zinc Chloride (UNII: 86Q357L16B) Product Characteristics Color WHITE, BLUE (White and Blue stripes) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63956-003-03 1 in 1 CARTON 07/30/2019 1 75 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 07/30/2019 Labeler - EMAG AG (343617614) Establishment Name Address ID/FEI Business Operations Durodont GmbH 341254136 MANUFACTURE(63956-003)