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

Medically reviewed by Drugs.com. Last updated on July 17, 2020.

Dosage form: ointment
Ingredients: HYDROCORTISONE 5mg in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0016

Further information

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

HYDROCORTISONE OINTMENT 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

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

W5157B

R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC 0168-0016-31

HYDROCORTISONE OINTMENT USP, 0.5%

ANTI-ITCH OINTMENT

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC 0168-0016-31

HYDROCORTISONE OINTMENT USP, 0.5%

ANTI-ITCH OINTMENT

NET WT 28.35g (1 Oz)

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
mineral oil 
Packaging
#Item CodePackage Description
1NDC:0168-0016-311 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/1981
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

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

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