Label: HYDROCORTISONE cream

  • NDC Code(s): 71399-0180-1, 71399-0180-2
  • Packager: AKRON PHARMA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2023

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

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

    • eczema
    • insect bites
    • poison ivy or sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry,
    • seborrheic dermatitis
    • poison oak
    • psoriasis
    • temporarily relieves external anal and genital itching
    • Other uses of this product should be undertaken only under the advice and supervision of a doctor.
  • Warnings

    For external use only.

  • Do not use

    • in the genital area if you have a vaginal discharge.
    • for the treatment of diaper rash, Consult a doctor.
  • When using this product

    • avoid contact with eyes
    • do not use more thatn directed unless told to do so by a doctor
    • do not put directly into the rectumby using fingers or any mechanical device or applicator
  • 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. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
    • rectal bleeding occurs.
  • Keep out of Reach of Children

    If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

  • Directions

    for itching of skin irritation, inflammation, and rashes:

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor

    for external anal and genital itching, adults:

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • Other Information

    Store at 20-250C (68-770F).

  • Inactive Ingredients

    aloe vera, benzyl alcohol, glyceryl monostearate, mineral oil, PEG-40, PEG-25, propylene glycol, purified water, squalane, stearic acid.

  • Questions or Comments?

    Call toll-free 1-877-225-6999

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Akron Pharma, Inc.
    Fairfield, NJ 07004

    www.akronpharma.com

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    16Oz

    1Oz

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0180-1454 g in 1 JAR; Type 0: Not a Combination Product11/05/2021
    2NDC:71399-0180-21 in 1 CARTON11/20/2023
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/05/2021
    Labeler - AKRON PHARMA INC (067878881)