Label: HYDROCORTISONE CREAM- hydrocortisone cream

  • NDC Code(s): 69396-096-16
  • Packager: Trifecta Pharmaceuticals USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2025

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

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

    For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to:

    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • temporarily relieves external anal and genital itching

    Other use of this product should be only under the advice and supervision of a doctor

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    • for external use only

  • Stop using this product and ask a doctor

    • Conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.
    • Rectal bleeding occurs
  • When using this product

    When using this product

    • avoid contact with the 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.
  • Do not use

    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.

  • Directions

    For itching of skin irritation, inflammation, and rashes:

    Adults and Children 2 years 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.

  • Inactive Ingredients

    Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.

  • Other Information

    • store at controlled room temperature 20°- 25°C (68°-77°F)

  • Questions

    Call 1-888-296-9067

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    This product is not manufactured or distributed by Chattem, Inc. distributor of Cortizone-10.

  • Package Label

    4075 GLOBE HYDROCORTISONE CREAM WITH ALOE 16OZ REV08 042725 CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-096
    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
    EDETIC ACID (UNII: 9G34HU7RV0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    3-METHYLPENTADECANE (UNII: X64R3JC095)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-096-16454 g in 1 JAR; Type 0: Not a Combination Product01/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/13/2022
    Labeler - Trifecta Pharmaceuticals USA (079424163)