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
  • 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 27, 2021

If you are a consumer or patient please visit this version.

  • 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

  • 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 not finalpart34801/24/2007
    Labeler - Bentlin Products LLC (832615426)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(47832-205)