DOSAGE & ADMINISTRATION SECTION.


Directions:For minor skin irritations and rashes,adults and children years of age and older: apply to affected area not more than to times daily .For external anal itching:adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or soft cloth before application of this productchildren: under 12 years of age, consult doctor.. adults and children years of age and older: apply to affected area not more than to times daily .. 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 doctor.

INULLCTIVE INGREDIENT SECTION.


Inactive Ingredients. benzyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, paraffin, polyoxyl 40 stearate, potassium sorbate, purified water, sorbitan monostearate and stearyl alcohol.

INDICATIONS & USAGE SECTION.


Uses:for temporary relief of itching associated with minor skin irritations and rashes due to:eczemainsect bitessoaps and detergentscosmeticsjewelryseborrheic dermatitispsoriasispoison ivy oak or sumacfor external genital, feminine and anal itchingother uses of this product should be only under the advice and supervision of doctor. 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 doctor.

OTC - ACTIVE INGREDIENT SECTION.


Active Ingredient:. Hydrocortisone mg.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


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

OTC - PURPOSE SECTION.


Purpose:. Anti-itch.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL PRINCIPAL DISPLAY PANEL CONTAINER. Fougera(R) NDC 0168-0014-31HYDROCORTISONE CREAM USP, 0.5%ANTI-ITCH CREAMNET WT 28.35g (1 Oz). PACKAGE LABEL PRINCIPAL DISPLAY PANEL LABEL.

SPL UNCLASSIFIED SECTION.


Other information:do not use if seal is punctured or is not visible. To open, reverse cap to puncture sealstore at room temperaturesee crimp of tube for Lot Number and Expiration Date. 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.

WARNINGS SECTION.


Warnings:For external use onlyDo not usein children under years of ageif you have vaginal dischargefor the treatment of diaper rashAsk doctor before use if you haveexternal genital or feminine itchingexternal anal itchingbleedingWhen using this productavoid contact with eyesdo not exceed the recommended daily dosage unless directed by doctordo not put this product into the rectum by using fingers or any mechanical device or applicatorStop use and ask doctorif condition worsens, or if symptoms persist for more than days or clear up and occur again within few days, stop use and do not begin use of any other hydrocortisone product. in children under years of age. if you have vaginal discharge. for the treatment of diaper rash. external genital or feminine itching. external anal itching. bleeding. avoid contact with eyes. do not exceed the recommended daily dosage unless directed by doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator. if condition worsens, or if symptoms persist for more than days or clear up and occur again within few days, stop use and do not begin use of any other hydrocortisone product.