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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 31, 2023

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 not finalpart34805/31/2023
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)