Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

  • NDC Code(s): 68016-009-01
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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

  • Drug Facts

  • Active ingredient

    Hydrocortisone, USP 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor irritations, inflammation, and rashes due to
      • eczema
      • psoriasis
      • insect bites
      • poison ivy, oak, sumac
      • detergents,
      • jewelry,
      • cosmetics
      • soaps
      • seborrheic dermatitis
    • temporarily relieves external anal and genital itching
    • other uses of this product should be 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. Consult a doctor.
    • for the treatment of a diaper rash. Consult.

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless directed by a doctor
    • do not put directly into the rectum by 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
    • do not begin the use of any other hydrocortisone product unless directed by a doctor
    • rectal bleeding occurs

    Keep out of reach of children.

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

  • Directions

    • for itching of skin irritation, inflammation, and rashes
      • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
      • children under 2 years of age: consult a doctor
    • for external anal and genital itching
      • adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
      • apply to the affected area not more than 3 to 4 times daily
      • children under 12 years of age: consult a doctor
  • other information

    • store at 15º-30ºC (59º-86ºF). Protect from freezing.
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    mineral oil, white petrolatum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®*

    MAXIMUM STRENGTH

    Hydrocortisone Ointment, USP 1%

    ANTI-ITCH OINTMENT

    Relieves

    Itches and

    Rashes

    NET WT. OZ (g)

    For the temporary relief of itching associated with minor skin irritations, inflammation and rashes

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

  • Package label

    Hydrocortisone USP, 1%

    PREMIER VALUE Maximum Strength Anti-Itch Ointment

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  MAXIMUM STRENGTH
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-009-011 in 1 CARTON09/08/2006
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/08/2006
    Labeler - Chain Drug Consortium, LLC (101668460)