Label: EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 63956-001-90 - 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 April 22, 2014
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- Official Label (Printer Friendly)
- emmi dent Sodium Fluoride Anticavity Toothpaste Mild
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults and children 2 years 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: Consult a dentist or doctor.
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Inactive Ingredients
water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral
- Representative Labeling
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INGREDIENTS AND APPEARANCE
EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63956-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.16 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ALLANTOIN (UNII: 344S277G0Z) LIMONEN-10-OL, (+)- (UNII: 1Q8KVB0R3J) CHAMOMILE (UNII: FGL3685T2X) THREE-LOBE SAGE (UNII: 3V97D33N0K) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63956-001-90 1 in 1 PACKAGE 1 90.6 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/22/2014 Labeler - EMAG AG (343617614) Registrant - EMAG AG (343617614) Establishment Name Address ID/FEI Business Operations EMAG AG 343617614 manufacture(63956-001)