PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


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)

OTC - ACTIVE INGREDIENT SECTION.


Active Ingredient: Hydrocortisone 5 mg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION.


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

DOSAGE & ADMINISTRATION SECTION.


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.


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

INACTIVE INGREDIENT SECTION.


Inactive Ingredients mineral oil and white petrolatum

WARNINGS SECTION.


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

OTC - PURPOSE SECTION.


Purpose: Anti-itch