Label: MAXIMUM STRENGTH CORTISONE- hydrocortisone ointment ointment

  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2021

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

  • Active Ingredient

    Hydrocortisone, USP 1%

  • Purpose


  • 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, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, 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 external feminine itching if you have a vaginal discharge.  Consult a doctor.

    for the treatment of diaper rash.  Consult a doctor.

  • When using this product

    avoid contact with the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed 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

    symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

  • 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 * do not use, consult a doctor.

    For external anal 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 applicaion of this product.

    Children under 12 years of age: consult a doctor.

  • Other information

    Store at room temperature 59o-86oF (15o-30oC).

    Before using any medication, read all label directions.  Keep carton, it contains important information.

  • Inactive Ingredients

    mineral oil, white petrolatum

  • Carton Label


  • Tube Label


    hydrocortisone ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 96.98 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 2 g  in 100 g
    Product Characteristics
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-259-031 in 1 CARTON11/01/2016
    1NDC:69842-259-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2016
    Labeler - CVS Pharmacy (062312574)
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(69842-259)