HYDROCORTISONE CREAM- hydrocortisone cream 
Trifecta Pharmaceuticals USA

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Hydrocortisone Cream 1%

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

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

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 Anal Itching Users:

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

Stop using this product and ask a doctor

Do not use this product and ask a doctor

Directions

Inactive Ingredients

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

Other Information

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 042525 CDER

Label

404004-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 4PK_BOX 042525 CDER

Package Label

404003-FBA GLOBE HYDROCORTISONE CREAM WITH ALOE 1OZ 3PK_BOX 042525 CDER

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
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SORBITAN STEARATE (UNII: NVZ4I0H58X)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONO- AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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)

Revised: 5/2025
Document Id: 34a27d85-dac3-2169-e063-6294a90ae708
Set id: 4c96ec41-841c-322b-e054-00144ff8d46c
Version: 11
Effective Time: 20250508
 
Trifecta Pharmaceuticals USA