Label: HYDROCORTISONE- anti-pruritic cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active Ingredient

    Hydrocortisone 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.
    • Other uses of this product should only be under the advice and supervision of a doctor.
  • 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

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist 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.
    • bleeding occurs near anus when used for anal itching

    If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) 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

    Store at room temperature

  • Inactive Ingredients

    Cetostearyl Alcohol, Glyceryl Palmitostearate, Kathon, Petrolatum, Propylene Glycol, Stearic Acid, Tea Leaf, Water

  • Questions and Comments?

    1-888-396-2739

  • Label PDP

    CR-1139 Hydrocortisone Cream PDP

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    anti-pruritic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0485
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0485-172 in 1 CASE01/18/2019
    11 in 1 BOX
    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 DrugM01701/18/2019
    Labeler - Cardinal Health (063997360)
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