HYDROCORTISONE CREAM USP, 1%

Manufacturer
A-S Medication Solutions
Effective date
2018-01-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:03:59

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredient (in each gram):

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 10 mg

Purpose:

OTC - PURPOSE SECTION

Anti-itch

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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.

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc., Melville, NY 11747
W5159B
R11/11

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2359

NDC: 50090-2359-0 1.5 g in a PACKET

HYDROCORTISONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2359-0GM - Gram50090-2359a0afd499-be91-452a-aab1-365e479f394312019-02-13
0168-0154-08GM - Gram0168-0154b3aeb74c-bb26-4575-ba8e-701e0ccbd31f12014-10-03
0168-0154-31GM - Gram0168-0154186635df-94e4-4c82-9db9-5923d8edb99812014-10-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-235950090-2359-0
0168-0154

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fb486a57-6476-46cf-a3ed-642fff2b8917ffd80bad-3a32-4f74-bebb-2afe8d1f048f2018-08-23WarningsExact identifier
spl set id: ffd80bad-3a32-4f74-bebb-2afe8d1f048f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.