HYDROCORTISONE 1%- hydrocortisone cream 
Trifecta Pharmaceuticals Usa Llc

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Globe Hydrocortisone Cream 1%















MAXIMUM STRENGTH

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (Anti-Itch)

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

Warnings

For external use only

When using this product

Stop using this product and ask a doctor if

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.

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

LABEL

1016SL GLOBE HYDROCORTISONE CREAM WITHOUT ALOE 0.9G 144CT 073125 CDER

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)

Revised: 8/2025
Document Id: 3d0e62b4-838c-5fb2-e063-6394a90a1444
Set id: f4d4a56b-b4b7-9a07-e053-2a95a90ad853
Version: 4
Effective Time: 20250823
 
Trifecta Pharmaceuticals Usa Llc