Label: CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone ointment ointment

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

Drug Label Information

Updated August 2, 2024

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

  • Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch 

  • Uses

    ■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics

    ■ soaps ■ seborrheic dermatitis

    ■ temporarily relieves external anal and genital itching

    ■ other uses of this product should only be under the advice and supervision of a doctor

  • Warnings 

    For external use only 

  • Do not use 

    ■ in the genital area 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 eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor

  • 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 

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
    • children under 2 years of age: ask a doctor

    for external anal itching,

    • adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently 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 20-25°C ( 68-77°F)
    • before using any medication read all label direction, keep carton it contains important information 
  • Inactive ingredient 

    Petrolatum 

  • Questions? 1-800-222-1087

  • Principal Display Panel 

    CVS              NDC 51316-165-28    

    Maximum strength

    Cortisone Ointment 

    Hydrocortisone 1%

    NET WT 1.0 OZ  (28g)

    503200-CVSHealth-Max-Strength-Cortisone-Ointment-1-oz-Carton

    203200-CVS -Tube _Hydrocortisone Ointment

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE 
    hydrocortisone ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-165
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-165-281 in 1 CARTON06/01/2024
    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 DrugM01706/01/2024
    Labeler - CVS Health (062312574)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(51316-165) , analysis(51316-165)