Label: HYDROCORTISONE CREAM- hydrocortisone cream

  • NDC Code(s): 69396-028-01, 69396-028-02, 69396-028-33, 69396-028-44
  • Packager: Trifecta Pharmaceuticals USA
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 28, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

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

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

    Other uses 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
    • avoid contact with eyes
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    For External Anal Itching Users:

    • do not exceed the recommended daily dosage unless directed by a doctor
    • in case of bleeding, consult a doctor promptly
    • children under 12 years of age: consult a doctor

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

  • Stop using this product and ask a doctor

    • in case of bleeding
    • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • before you begin using any other hydrocortisone product
  • Do not use this product and ask a doctor

    • If you have a vaginal discharge
    • before treating diaper rash
    • before using on children under 2 years of age
  • Directions

    • When practical, cleanse 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
    • adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
    • children under 12 years of age: do not use, consult a doctor
  • Inactive Ingredients

    Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate

  • Other Information

    • to open; unscrew cap and pull tab to remove foil seal
    • if seal has been broken, do not use this product. Return product to the store where you bought it
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see carton or tube crimp for lot number and expiration date
  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    1-888-296-9067

  • Package Label

    4040 GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ REV04 12222 CDER

  • Label

    8899-FBA-4 GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 4PK_BOX 101323 CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-028
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-028-011 in 1 BOX04/07/2017
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-028-021 in 1 BOX04/07/2017
    256 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69396-028-444 in 1 BOX02/07/2024
    328.4 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69396-028-333 in 1 BOX02/28/2024
    428.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/07/2017
    Labeler - Trifecta Pharmaceuticals USA (079424163)