Label: HYDROCORTISONE 1%- hydrocortisone cream

  • NDC Code(s): 69396-118-09, 69396-118-25
  • Packager: Trifecta Pharmaceuticals Usa Llc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • DRUG FACTS

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Antipruritic (Anti-Itch)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • Uses

    For temporary relief of itching associated with minor skin irritations and rashes

    ● external feminine, genital and anal itching

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

  • Do Not Use

    • For the treatment of diaper rash, consult a doctor.
    • With any other Hydrocortisone product unless you have consulted a doctor
    • If you have a vaginal discharge, consult a doctor

  • Warnings

    For external use only

  • When using this product

    • Avoid Contact with the eyes
    • do not exceed the recommended daily dosage unless directed by a doctor.
    • do not put this product into the rectum by using fingers or any mechanical device or applicator.

  • Stop using this product and ask a doctor if

    • conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
    • Rectal bleeding occurs
  • Directions

    Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

    Children under 2 years of age: do not use and ask a doctor.

    For External and anal itching in adults:

    When practical, clean 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

    For External anal and genital itching in children under 12 years of age:

    Ask a doctor

  • Inactive ingredients

    Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.

  • Other information

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

    Tamper evident, do not use if packet is torn, cut or opened.

    Avoid excessive heat and humidity.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Trifecta Pharmaceuticals USA™

    Ft. Lauderdale, FL 33301 USA

    Online: www.trifecta-pharma.com

    Reorder No. 1016SL

    To reorder call: 1-888-296-9067

    Fax: 888-878-3609

  • Questions

    Call 1-888-296-9067

  • PRINCIPAL DISPLAY PANEL

    Globe Hydrocortisone Cream 0.9g CDER

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 1% 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-118
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-118-09144 in 1 CARTON05/31/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-118-2525 in 1 BOX05/31/2023
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/31/2023
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)