Label: MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone, USP 1%

  • Purpose

    Antipruritic (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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
    • for external genital, feminine and anal 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

    • for the treatment of diaper rash. Consult a doctor.
    • for external feminine itching if you have a vaginal discharge. Consult a doctor.

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put this product into rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

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

    KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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: do not use. Consult a doctor.

    Adults: for external anal itching:

    • 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 application of this product

    Children under 12 years of age: for external anal itching, consult a doctor

  • Other information

    • store at room temperature
  • Inactive ingredients

    mineral oil, petrolatum

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    De La Cruz ®

    Anti-Itch

    Ointment

    Maximum Strength

    Hydrocortisone 1%

    For Relief of Itching, Rashes

    and Skin Irritations

    • Fragrance Free
    • Rapid Relief

    Net Wt. 1 OZ (28g)

    Hydrocortisone-01

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1560
    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:24286-1560-11 in 1 BOX03/22/2013
    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 DrugM01703/22/2013
    Labeler - DLC Laboratories, Inc (093351930)
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