HYDROCORTISONE CREAM- hydrocortisone cream 
Trifecta Pharmaceuticals USA

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Always Save 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

Directions

Adults and children 2 years and older

Children under 2 years of age

For external and anal ithcing

Do Not Use

When using this product

Stop Using this product and ask a doctor if

Questions

Call 1-800-883-0085

Inactive Ingredients

Cetyl alcohol, Edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.

Other Information

Store at controlled room temperature 20°C - 25°C (68°F - 77°F).

Other Information

Proudly Distributed By:

Associated Wholesale Grocers, Inc.

Kansas City, Kansas 66106

Label

AWGAS Hydrocortisone Cream 1 percent 1oz 081023 CDER

HYDROCORTISONE CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-147
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
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-147-011 in 1 BOX03/01/2024
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/20/2024
Labeler - Trifecta Pharmaceuticals USA (079424163)

Revised: 3/2024
Document Id: 141abdfb-56b5-2537-e063-6294a90a1871
Set id: 141aa2a7-8789-1127-e063-6294a90a2d23
Version: 1
Effective Time: 20240320
 
Trifecta Pharmaceuticals USA