Label: HAIR SANITY HAIR SANITY PART I- hydrocortisone acetate lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0246-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 17, 2020
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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INACTIVE INGREDIENT
Water, Sodium Lauroyl Methyl Isethionate, Acrylates Copolymer, Decyl Glucoside, Sodium Lauroamphoacetate, Sodium Methyl Cocoyl Taurate, Sodium Cocoyl Isethionate, Butylene Glycol, Glycereth-26, Cocamidopropyl Betaine, Fragrance, Glycerin, Glycol Stearate, Phenoxyethanol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Allantoin, BHT, Disodium EDTA, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Methylpropanediol, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Salicylic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract
- Hair Sanity Part I
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INGREDIENTS AND APPEARANCE
HAIR SANITY HAIR SANITY PART I
hydrocortisone acetate lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0246 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SALICYLIC ACID (UNII: O414PZ4LPZ) SALIX ALBA BARK (UNII: 205MXS71H7) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) ALLANTOIN (UNII: 344S277G0Z) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) GLYCOL STEARATE (UNII: 0324G66D0E) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) ISOMALT (UNII: S870P55O2W) RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P) METHYLPROPANEDIOL (UNII: N8F53B3R4R) 4-TERPINEOL, (+)- (UNII: HZK34LN80N) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0246-4 237 mL in 1 TUBE; Type 0: Not a Combination Product 04/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/18/2017 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0246) , manufacture(58443-0246) , label(58443-0246) , analysis(58443-0246)