Label: LEADER MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo
- NDC Code(s): 70000-0531-1
- Packager: Cardinal Health, 110 dba LEADER
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 13, 2024
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- PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label
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INGREDIENTS AND APPEARANCE
LEADER MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0531 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q) Selenium Sulfide 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48) Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B) COCO MONOETHANOLAMIDE (UNII: C80684146D) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Chlorphenesin (UNII: I670DAL4SZ) Phenoxyethanol (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Sodium Chloride (UNII: 451W47IQ8X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0531-1 207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M032 11/05/2019 Labeler - Cardinal Health, 110 dba LEADER (063997360) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC 255106239 MANUFACTURE(70000-0531)