HYDROCORTISONE 1%- hydrocortisone cream 
Trifecta Pharmaceuticals Usa Llc

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.

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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

Globe Hydrocortisone Cream 0.9g 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 not finalpart34805/31/2023
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 5/2023
Document Id: fd06a5e7-32da-72bc-e053-6394a90a460d
Set id: f4d4a56b-b4b7-9a07-e053-2a95a90ad853
Version: 2
Effective Time: 20230531
 
Trifecta Pharmaceuticals Usa Llc