Label: HYDROCORTISONE- hydrocortisone continuous spray aerosol, spray

  • NDC Code(s): 56104-250-00
  • Packager: Premier Brands of America, 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 26, 2023

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  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • jewelry
    • detergents
    • cosmetics
    • seborrheic dermatitis
    • psoriasis
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only.

    Flammable:

    Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    Do not use

    • for external genital, vaginal or anal itching
    • with other hydrocortisone product unless directed by a doctor
    • in or near the eyes
    • for diaper rash

    When using this product

    • avoid contact with the eyes
    • if product gets into the eye, flush with water for 15 minutes

    Stop use and ask a doctor if

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

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • twist cap counterclockwise to unlock actuator
    • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, consult a doctor
    • to apply to face, spray into palm of hand and gently apply
  • Inactive ingredients

    aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

  • Questions ?

    Call 1-866-964-0939

  • Principal Display Panel

    Cutter
    Poison Ivy Itch Relief

    For Poison Ivy, Oak, & Sumac

    Maximum Strength

    Relieves Itching

    Calms irritated skin

    No touch, no mess

    HYDROCORTISONE 1% / ANTI-ITCH

    NET WT 4.0 0Z (113 g)

    Artwork

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.13 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    OAT (UNII: Z6J799EAJK)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ALCOHOL (UNII: 3K9958V90M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-250-00113 g in 1 CAN; Type 0: Not a Combination Product12/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/20/2021
    Labeler - Premier Brands of America, Inc. (117557458)
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