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

Dosage form: ointment
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0181

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 OINTMENT USP, 1%

Active Ingredient (in each gram):

Hydrocortisone 10 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

mineral oil and white petrolatum

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc., Melville, NY 11747
W5160B
R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC 0168-0181-31

HYDROCORTISONE OINTMENT USP, 1%

ANTI-ITCH OINTMENT
MAXIMUM STRENGTH
available without prescription

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC 0168-0181-31

HYDROCORTISONE OINTMENT USP, 1%

ANTI-ITCH OINTMENT
MAXIMUM STRENGTH
available without prescription

NET WT 28.35g (1 Oz)

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0181
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
mineral oil 
Packaging
#Item CodePackage Description
1NDC:0168-0181-311 TUBE in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/06/1975
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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Medically reviewed on Sep 24, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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