HYDROCORTISONE- hydrocortisone ointment 
TRIFECTA PHARMACEUTICALS USA LLC

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Always Save Hydrocortisone OINTMENT 1%

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
●detergents ● cosmetics ● jewelry ●external feminine genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor.

Warnings

for external use only

Directions

Adults and children 2 years and older

Children under 2 years of age:

For External and anal itching:

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.

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

Inactive ingredients Light Mineral Oil, Petrolatum

Do Not Use

Do Not use

Other Information

Distributed By

Proudly Distributed By:

Associated Wholesale Grocers Inc.

Kansas City, Kansas 66106

Stop using this product and ask a doctor if

When Using This Product

Questions:

Call 1-800-883-0085

Packaging

AWGAS Hydrocortisone Ointment 1 percent 1oz 081023 CDER

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-149
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-149-011 in 1 BOX03/14/2024
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 DrugM01703/10/2024
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 3/2024
Document Id: 1369e776-6fdf-6e18-e063-6394a90aee3b
Set id: 1369e70f-7a61-7078-e063-6394a90a9a88
Version: 1
Effective Time: 20240311
 
TRIFECTA PHARMACEUTICALS USA LLC