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

Dosage form: cream
Ingredients: HYDROCORTISONE 5mg in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0014

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:

  • 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)

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)

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
glycerin 
glyceryl monostearate 
isopropyl palmitate 
lactic acid 
paraffin 
polyoxyl 40 stearate 
potassium sorbate 
water 
sorbitan monostearate 
stearyl alcohol 
Packaging
#Item CodePackage Description
1NDC:0168-0014-311 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/01/1968
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 07/2012
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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