Label: LEADERS MEDIU ELASTICITY GOLD PACK- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69424-470-01 - 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, Cetyl Ethylhexanoate, Butylene Glycol, Glyceryl Stearate, Polysorbate 60, Mica, PEG-100 Stearate, Titanium Dioxide, Iron Oxides, Gold, Zanthoxylum Piperitum fruit extract, Pulsatilla koreana extract, Usnea barbata (lichen) extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trehalose, Betaine, Carbomer, Tromethamine, Fragrance, PVP, Sodium Citrate, Disodium EDTA
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADERS MEDIU ELASTICITY GOLD PACK
dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69424-470 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.2 g 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:69424-470-01 10 mL in 1 CELLO PACK; 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(69424-470)