Label: PIGMENT- hydroquinone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 65113-9003-1, 65113-9003-2 - Packager: G.S. COSMECEUTICAL USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC Monograph Drug Product Manufactured Exclusively for Private Label Distributor
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 15, 2011
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- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL - 29.5 mL Label
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INGREDIENTS AND APPEARANCE
PIGMENT
hydroquinone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65113-9003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LACTIC ACID (UNII: 33X04XA5AT) AZELAIC ACID (UNII: F2VW3D43YT) KOJIC ACID (UNII: 6K23F1TT52) HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: S38J6RZN16) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) GLUTATHIONE (UNII: GAN16C9B8O) SILYBUM MARIANUM SEED (UNII: U946SH95EE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Product Characteristics Color YELLOW (LIGHT YELLOW) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65113-9003-1 7.4 mL in 1 BOTTLE, PLASTIC 2 NDC:65113-9003-2 29.5 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 05/26/2011 Labeler - G.S. COSMECEUTICAL USA, INC. (017014734) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE
