Label: LEADERS MEDIU PURIFYING SALT PACK- allantoin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69424-490-01 - Packager: SANSUNG LIFE & SCIENCE 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 February 1, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Glycerin, Dipropylene Glycol, Butylene Glycol, Alcohol, Bentonite, Kaolin, Magnesium Aluminum Silicate, Polyvinyl Alcohol, Titanium Dioxide, Caprylic/Capric Triglyceride, Betaine, Sodium Chloride, Decylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Boswellia serrata resin extract, Fragrance, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan gum, Ferric Ammonium Ferrocyanide, Isohexadecane, Polysorbate 80, Rubus coreanus fruit extract, Cnidium officinale root extract, Snail secretion filtrate, Disodium EDTA, CI 19140, CI 42090, Totarol
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADERS MEDIU PURIFYING SALT PACK
allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69424-490 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 50 mg in 10 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69424-490-01 10 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/01/2015 Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929) Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929) Establishment Name Address ID/FEI Business Operations SANSUNG LIFE & SCIENCE CO., LTD. 689524929 manufacture(69424-490)