Hydrocortisone by A2A Integrated Pharmaceuticals, LLC HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by A2A Integrated Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• insect bites
• poison ivy, oak, or sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriarsis
• temporarity relieves external anal and genital itching
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)

Directions

• for itching of skin irritation, inflammation, and rashes:
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, ask a doctor
• for external anal and genital itching, adults:
• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

Cetyl alcohol, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions or comments?

Call 1(800)380-6709

Distributed By:

A2A Integrated Pharmaceuticals

Bowling Green, KY 42101

Carton Label

NDC: 73141-622-28

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1 OZ (28g)

Jar Label

NDC: 73141-622-54

Hydrocortisone Cream 1%

Maximum Strength Anti-Itch Cream

NET WT 1LB (454g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73141-622
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73141-622-28	1 in 1 CARTON	03/28/2025
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73141-622-54	454 g in 1 JAR; Type 0: Not a Combination Product	03/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/28/2025

Labeler - A2A Integrated Pharmaceuticals, LLC (117064671)