Label: MAXIMUM STRENGTH HYDROCORTISONE ANTI-ITCH- hydrocortisone 1% cream

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

Drug Label Information

Updated January 17, 2024

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

  • Drug Facts 

  • Active Ingredient

    Hydrocortisone 1.0%

  • Purpose

    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
    • external feminine, genital 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 genital itching if you have a vaginal discharge, consult a doctor.

    When using this product 

    • avoid contact with eyes
    • do not use more than directed unless told ot do so by a doctor
    • do not put this product 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, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
    • rectal bleeding occurs 
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • 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, clean 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 a controlled room temperature 20 - 25ºC (68 - 77ºF).

  • Inactive Ingredients:

     Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

  • Questions & Comments ? 1-800-910-6874

  • Principal Display Panel 

    Target Up&Up       NDC 11673-890-56

    Maxminium Strenght Hydrocortisone Cream 

    Hydrocortisone 1%

    Anti-itch 

    NET WT 2OZ (56g)

    TOTAL NET WT 4OZ (112g)

    256994 Tube

    556994 Carton

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HYDROCORTISONE ANTI-ITCH 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-890
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-890-562 in 1 CARTON01/31/2024
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/31/2024
    Labeler - Target Corporation (006961700)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11673-890) , analysis(11673-890)