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.

----------

HYDROCORTISONE CREAM USP, 0.5%

Active Ingredient:

Hydrocortisone 5 mg

Purpose:

Anti-itch

Uses:

Warnings:

For external use only

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor

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,

For external anal itching:

Other information:

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)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL

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)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 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 (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 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/1968
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 7/2012
Document Id: c93b88e1-c15b-42ba-a8fb-7bbc37cdc0bb
Set id: b600a0ef-104e-4051-9e48-9022eed5a7d9
Version: 1
Effective Time: 20120726
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.