Label: HYDROCORTISONE cream

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

Drug Label Information

Updated October 24, 2023

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

  • Drug Facts

  • Active ingredient (in each gram)

    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 • sunburn • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under 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 persists 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
    • rectal bleeding occurs

    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 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 room temperature 68°-77°F(20°-25°C).
    • tamper-evident: do not use if foil seal is broken or missing.
  • Inactive ingredients

    2-phenoxyethanol, aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, ginger oil, glycerin, glyceryl stearate, maltodextrin, methyl gluceth-20, methylparaben, methylpentadecane, petrolatum, polysorbate 80, propylene glycol, purified water, stearic acid, trisodium citrate dihydrate, vitamin E

  • Questions?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-227
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-227-001 in 1 BOX10/15/2022
    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 DrugM01710/15/2022
    Labeler - CVS PHARMACY, INC (062312574)