Label: HYDROCORTISONE (antipruritic- anti-itch ointment

  • NDC Code(s): 68001-526-45
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • Drug Facts

  • Active ingredient

    Hydrocortisone Acetate USP 1%

  • Purpose

    Antipruritic (Anti-Itch)

  • Uses

    For 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, and for external genital, feminine, and anal itching.

  • Warnings

    For external use only

    If pregnant or breast-feeding,

    ask a health professional before use

    Do not use

    • in the eyes
    • for diaper rash
    • for external genital or feminine itching if you have a vaginal discharge
    • more than the recommended daily dosage unless directed by a doctor
    • this product in the rectum by using fingers or any mechanical device or applicator

    Ask a doctor before use if you are using any other hydrocortisone product

    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 continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching

    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 of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
    • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.
    • Children under 12: consult a doctor before using for anal itching.
  • Other Information

    • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
    • Store at room temperature
    • Avoid excessive heat
    • Preserve in well-closed container
    • See crimp of tube or carton for Lot Number and Expiry Date
  • Inactive Ingredients

    Mineral Oil, Sorbitan Sesquioleate, White Petrolatum

  • Questions?

    Contact 1-800-707-4621

    Manufactured in India by:

    Gopaldas Visram & Company Limited

    Plot No. A327, T.T.C Indl. Area, M.I.D.C

    Mahape, Navi Mumbai - 400710.

    Mfg. Lic. No.: KD/503

    For BluePoint Laboratories

    Rev 01/2022

  • Label

  • PRINCIPAL DISPLAY PANEL

    Hydrocortisone Ointment, USP 1%

    Tube

  • PRINCIPAL DISPLAY PANEL

    cartonHydrocortisone Ointment, USP 1%

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    antipruritic (anti-itch) ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-526
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-526-451 in 1 CARTON05/17/2023
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/17/2023
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-526)
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