Label: H PLUS HOLDINGS NOURISHING- hydrocortisone acetate shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0412-3 - Packager: Prime Enterprises
- 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 October 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- WHEN USING
- ASK DOCTOR
- Keep out of reach of children.
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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
4-Terpineol, Acrylates Copolymer, Allantoin, Benzyl Alcohol, BHT, Butylene Glycol, Caprylic/Capric Triglyceride, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycereth-26, Glycerin, Glycol Stearate, Guar Hydroxypropyltrimonium Chloride, Isomalt, Isopropyl Palmitate, Lactic Acid, Lecithin, Menthol, Methylpropanediol, Phenoxyethanol, Poloxamer 407, Polyglyceryl-4 Laurate, Rhododendron Ferrugineum Leaf Cell Culture Extract, Salicylic Acid, Salix Alba (Willow) Bark Extract, Sea Whip Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sodium Lauroamphoacetate, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Water
- Hair Sanity Anti-Itch Shampoo Step 1 - 3 Fl. Oz.
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INGREDIENTS AND APPEARANCE
H PLUS HOLDINGS NOURISHING
hydrocortisone acetate shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLOXAMER 407 (UNII: TUF2IVW3M2) WILLOW BARK (UNII: S883J9JDYX) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6) ALLANTOIN (UNII: 344S277G0Z) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) LACTIC ACID (UNII: 33X04XA5AT) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCOL STEARATE (UNII: 0324G66D0E) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) ISOMALT (UNII: S870P55O2W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Product Characteristics Color white (White Pearl) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0412-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/12/2019 Labeler - Prime Enterprises (101946028) Registrant - Prime Enterprises (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 manufacture(58443-0412) , label(58443-0412) , analysis(58443-0412) , pack(58443-0412)
