HYDROCORTISONE CREAM- hydrocortisone cream 
Trifecta Pharmaceuticals USA

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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Hydrocortisone Cream 1%

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

For temporarily rellief of itching associated with minor skin irritations, inflammation and rashes due to:

Other use 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

Stop using this product and ask a doctor

When using this product

When using this product

Do not use

Do not Use

Directions

Adults and Children 2 years and older

Children under 2 years of age

For external and anal itching

Children under 12 years of age with external and anal itching: Consult a doctor.

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, glycerin, Glycerol Stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2-Phenoxyethanol, Polysorbate 80, Propylene Glycol, purified water, Stearic Acid, Trisodium citrate dihydrate, Vitamin E.

Other Information

Questions ?

Call 1-888-296-9067

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

This product is not manufactured or distributed by Chattem, Inc. distributor of Cortizone-10.

Package Label

4075 GLOBE HYDROCORTISONE CREAM WITH ALOE 16OZ REV07 121922 CDER

HYDROCORTISONE CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-096
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
EDETIC ACID (UNII: 9G34HU7RV0)  
GINGER OIL (UNII: SAS9Z1SVUK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
3-METHYLPENTADECANE (UNII: X64R3JC095)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-096-16454 g in 1 JAR; Type 0: Not a Combination Product01/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/13/2022
Labeler - Trifecta Pharmaceuticals USA (079424163)

Revised: 9/2023
Document Id: 065de60d-bd33-6cef-e063-6394a90a25c7
Set id: d57a59fb-c8f2-f73b-e053-2995a90a4cdb
Version: 5
Effective Time: 20230927
 
Trifecta Pharmaceuticals USA