- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.
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Inactive ingredients
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, Menthol, Benzyl Alcohol, Isopropyl Palmitate, Polyglyceryl-4 Laurate, Poloxamer 407, Citric Acid
- PRINCIPAL DISPLAY PANEL - 89 mL Tube Label
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INGREDIENTS AND APPEARANCE
HAIRSANITY STEP 1
hydrocortisone acetate shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71605-000 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 SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERETH-26 (UNII: NNE56F2N14) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) GLYCOL STEARATE (UNII: 0324G66D0E) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) ALLANTOIN (UNII: 344S277G0Z) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYLPROPANEDIOL (UNII: N8F53B3R4R) 4-TERPINEOL, (+)- (UNII: HZK34LN80N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) POLOXAMER 407 (UNII: TUF2IVW3M2) ISOMALT (UNII: S870P55O2W) SALICYLIC ACID (UNII: O414PZ4LPZ) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) SALIX ALBA BARK (UNII: 205MXS71H7) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) BENZYL ALCOHOL (UNII: LKG8494WBH) RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71605-000-01 237 mL in 1 TUBE; Type 0: Not a Combination Product 08/10/2017 2 NDC:71605-000-04 89 mL in 1 TUBE; Type 0: Not a Combination Product 08/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 08/10/2017 Labeler - H Plus Holdings (080731249)