Label: E ENZYME- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 76414-010-01 - Packager: SAMJOKO SKYBLUE CO., LTD.
- 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 November 14, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, D-Sorbitol Liquefied, Colloidal Silcon Dioxide, ATTAPULGITE, PEG-1500, Sluminum chlorohydroxg allautonate, Aminocaparoid Acid, Sodium Saccharine, XYLITOL, Butyl-P oxybenzoare, Hydroxyapatite, Carbon hydrozen Sodium, GLYCERIN, Carboxymethylcellulose nattrium, Sulfuricacid, GRAPEFRUIT SEED OIL, GREEN TEA LEAF, PROPOLIS WAX, I-mentol, Optimint
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
E ENZYME
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76414-010 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 1.2 g in 200 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ATTAPULGITE (UNII: U6V729APAM) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) GRAPEFRUIT SEED OIL (UNII: 598D944HOL) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PROPOLIS WAX (UNII: 6Y8XYV2NOF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76414-010-01 200 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/01/2011 Labeler - SAMJOKO SKYBLUE CO., LTD. (557804810) Registrant - SAMJOKO SKYBLUE CO., LTD. (557804810) Establishment Name Address ID/FEI Business Operations SAMJOKO SKYBLUE CO., LTD. 557804810 manufacture