HYDROCORTISONE

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

HYDROCORTISONE OINTMENT USP, 0.5%

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient:
• Purpose:
• Keep out of reach of children.
• Inactive Ingredients
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FULL PRESCRIBING INFORMATION

Active Ingredient:

Hydrocortisone 5 mg

Purpose:

Anti-itch

Uses

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:

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.

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.

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

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)