HYDROCORTISONE by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE ointment

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Hydrocortisone 5 mg

Purpose:

Anti-itch

INDICATIONS & USAGE

Uses:

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

WARNINGS

Warnings:

For external use only

Do not use

• in children under 2 years of age
• if you have a vaginal discharge
• for the treatment of diaper rash

Ask a doctor before use if you have

• external genital or feminine itching
• external anal itching
• bleeding

When using this product

• avoid contact with eyes
• do not exceed the recommended daily dosage 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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions:

For minor skin irritations and rashes,

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily .

For external anal 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 application of this product
• children: under 12 years of age, consult a doctor.

SPL UNCLASSIFIED SECTION

Other information:

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
• store at room temperature
• see crimp of tube for Lot Number and Expiration Date

Inactive Ingredients

mineral oil and white petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

W5157B

R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0016-31

HYDROCORTISONE OINTMENT USP, 0.5%

ANTI-ITCH OINTMENT

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC: 0168-0016-31

HYDROCORTISONE OINTMENT USP, 0.5%

ANTI-ITCH OINTMENT

NET WT 28.35g (1 Oz)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
petrolatum (UNII: 4T6H12BN9U)
mineral oil (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0016-31	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	01/01/1981

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)