Label: EMMI-DENT FRESH- sodium fluoride paste, dentifrice
- NDC Code(s): 63956-004-01
- Packager: EMAG AG
- Category: HUMAN OTC DRUG LABEL
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
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Inactive ingredients
water, sorbitol, hydrated silica, propylene glycol, tetrapotassium pyrophosphate, xanthan gum, sodium C-14-16 olefin sulfonate, aroma, mentha arvenis leaf oil, titanium dioxide, sodium methyl paraben, sodium saccharin, allantoin, chamomilla recutita (matricaria) flower extract, salvia triloba leaf extract
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton
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INGREDIENTS AND APPEARANCE
EMMI-DENT FRESH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63956-004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 199 mg in 75 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Propylene Glycol (UNII: 6DC9Q167V3) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) Xanthan Gum (UNII: TTV12P4NEE) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Mentha Arvensis Leaf oil (UNII: 1AEY1M553N) Titanium Dioxide (UNII: 15FIX9V2JP) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Allantoin (UNII: 344S277G0Z) CHAMOMILE (UNII: FGL3685T2X) THREE-LOBE SAGE (UNII: 3V97D33N0K) Product Characteristics Color WHITE (white homogeneous mass) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63956-004-01 1 in 1 CARTON 07/15/2019 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 07/15/2019 Labeler - EMAG AG (343617614) Establishment Name Address ID/FEI Business Operations Durodont GmbH 341254136 MANUFACTURE(63956-004)