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

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

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

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

W5156B

R11/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0014-31

HYDROCORTISONE CREAM USP, 0.5%

ANTI-ITCH CREAM

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC: 0168-0014-31

HYDROCORTISONE CREAM USP, 0.5%

ANTI-ITCH CREAM

NET WT 28.35g (1 Oz)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0014
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
benzyl alcohol (UNII: LKG8494WBH)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
isopropyl palmitate (UNII: 8CRQ2TH63M)
lactic acid (UNII: 33X04XA5AT)
paraffin (UNII: I9O0E3H2ZE)
polyoxyl 40 stearate (UNII: 13A4J4NH9I)
potassium sorbate (UNII: 1VPU26JZZ4)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0014-31	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	01/01/1968

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