Label: HYDROCORTISONE ACETATE cream

  • NDC Code(s): 47832-205-05, 47832-205-15, 47832-205-34
  • Packager: Bentlin Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrocortisone acetate USP 1.0% w/w

  • Purpose

    Anti-itch

  • Uses:

    For temporary relief of itching associated with minor skin irritation, inflammation and rashes due to:

    • Atopic eczema
    • Contact dermatitis from soaps, detergents or 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

    Do not use

    • For the treatment of diaper rash
    • On children under the age of 2 except under the supervision of a doctor

    When using this product

    • Avoid contact with the eyes
    • Do not begin use any other hydrocortisone product unless directed by a doctor

    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

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

  • Directions

    Adults and children 2 years and older

    Apply to the affected area not more than 3 to 4 times daily.

    Children under 2 years of age

    Do not use. Consult a doctor.

  • Other Information

    Store between 20°-25°C (68°-77°F)

  • Inactive Ingredients

    caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water

  • Questions or comments?

    Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com

  • Principal Display Panel - 2 oz Carton Label

    NDC 47832-205-34

    exederm®

    flare control cream
    for eczema & dermatitis

    NET WT 2 OZ (56g)

    1% Hydrocortisone Anti-Itch Cream

    Principal Display Panel - 2 oz Carton Label

    Principal Display Panel - 2 oz Carton Label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47832-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47832-205-341 in 1 CARTON01/24/2007
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:47832-205-151 in 1 CARTON02/07/2018
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:47832-205-05576 in 1 CASE12/08/2014
    35 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/24/2007
    Labeler - Bentlin Products LLC (832615426)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(47832-205)
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