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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HYDROCORTISONE CREAM USP, 0.5%

Active Ingredient:

Hydrocortisone 5 mg

Purpose:

Anti-itch

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

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

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)

tubelabel

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)

CARTON
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
LACTIC ACID, UNSPECIFIED FORM (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0168-0014-311 in 1 CARTON01/01/196812/30/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/196812/30/2019
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 9/2019
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.