Label: H PLUS HOLDINGS NOURISHING- hydrocortisone acetate shampoo

  • NDC Code(s): 58443-0411-4
  • 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 August 25, 2021

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  • Active Ingredients

    Hydrocortisone acetate 1%

  • Purpose

    Antipuritic (Anti-Itch)

  • Uses

    • for the temporary relief of itching associated with minor skin irritations and rashes.
  • Warnings

    For external use only.

  • WHEN USING

    Avoid contact wih the eyes.

    If contact occurs, rinse eyes thoroughly with water.

  • ASK DOCTOR

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

  • 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.

  • Inactive Ingredients

  • Hair Sanity Anti-Itch Shampoo Step 1

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    H PLUS HOLDINGS  NOURISHING
    hydrocortisone acetate shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
    ALLANTOIN (UNII: 344S277G0Z)  
    RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)  
    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)  
    ISOMALT (UNII: S870P55O2W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    Colorwhite (White Pearl) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0411-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/12/2019
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0411) , label(58443-0411) , analysis(58443-0411) , pack(58443-0411)
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