Label: 1% KETOCONAZOLE ANTI DANDRUFF- 1% ketoconazole anti dandruff shampoo shampoo
- NDC Code(s): 84558-005-01
- Packager: GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 3, 2024
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Dea, Dimethicone, Sodium Chloride, Glycol Distearate,
Amino BispropyI Dimethicone, Fragrance, Polyquaternium-10, Carbomer, Azelaic Acid, L aurtrimonium Chloride, Guar
Hydroxypropyltrimonium Chloride, Methylisothiazolinone, Citric Acid, Coco/Oleamidopropyl Betaine, Dodecylbenzene Sulfonic
Acid, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen, Triethanolamine, Phenoxyethanol, AO1
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
1% KETOCONAZOLE ANTI DANDRUFF
1% ketoconazole anti dandruff shampoo shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84558-005 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) AQUA (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCAMIDE DEA (UNII: 92005F972D) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCOL DISTEARATE (UNII: 13W7MDN21W) CARBOMER (UNII: 0A5MM307FC) AZELAIC ACID (UNII: F2VW3D43YT) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CITRIC ACID (UNII: 2968PHW8QP) C12-15 PARETH-3 (UNII: 459EF9MP3Y) COCO/OLEAMIDOPROPYL BETAINE (UNII: 5M84PX7JN2) TRIETHANOLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84558-005-01 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/04/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/04/2024 Labeler - GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd (545488483) Establishment Name Address ID/FEI Business Operations GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd 545488483 manufacture(84558-005)