HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Unipack, Inc., ASIAN AEROSOL OAN PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema,
• insect bites,
• poison ivy,
• poison oak,
• poison sumac,
• soaps,
• jewelry,
• detergents,
• cosmetics,
• psoriasis,
• seborrheic dermatitis,
• for external genital, feminine and anal 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

• for external feminine itching 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 the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

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

Directions

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, consult a doctor.

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12 years of age:

• consult a doctor.

Other information

• Storage temperature: not to exceed 30oC (86oF).
• Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

mineral oil, white petrolatum

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Tube Label

Avedana ® Maximum Strength Hydrocortisone Ointment | 1oz Carton Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-251-01	1 in 1 CARTON	09/03/2021
1	NDC: 43749-251-03	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/03/2021

Labeler - Unipack, Inc. (009248480)

Registrant - ASIAN AEROSOL OAN PRIVATE LIMITED (872341020)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	label(43749-251)

Establishment
Name	Address	ID/FEI	Business Operations
ASIAN AEROSOL OAN PRIVATE LIMITED		872341020	manufacture(43749-251)