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#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each gram):
Hydrocortisone 10 mg
Purpose:
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.
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
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
Product: 50090-2359
NDC: 50090-2359-0 1.5 g in a PACKET
HYDROCORTISONE
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2359-0 | GM - Gram | 50090-2359 | a0afd499-be91-452a-aab1-365e479f3943 | 1 | 2019-02-13 |
| 0168-0154-08 | GM - Gram | 0168-0154 | b3aeb74c-bb26-4575-ba8e-701e0ccbd31f | 1 | 2014-10-03 |
| 0168-0154-31 | GM - Gram | 0168-0154 | 186635df-94e4-4c82-9db9-5923d8edb998 | 1 | 2014-10-03 |
Products#
Every source-derived product name is available through these pages.
- HYDROCORTISONE
- benzyl alcohol
- glycerin
- glyceryl monostearate
- isopropyl palmitate
- LACTIC ACID, UNSPECIFIED FORM
- paraffin
- polyoxyl 40 stearate
- potassium sorbate
- water
- sorbitan monostearate
- stearyl alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-2359 | 50090-2359-0 |
| 0168-0154 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| benzyl alcohol | LKG8494WBH | IACT |
| glycerin | PDC6A3C0OX | IACT |
| glyceryl monostearate | 230OU9XXE4 | IACT |
| isopropyl palmitate | 8CRQ2TH63M | IACT |
| LACTIC ACID, UNSPECIFIED FORM | 33X04XA5AT | IACT |
| paraffin | I9O0E3H2ZE | IACT |
| polyoxyl 40 stearate | 13A4J4NH9I | IACT |
| potassium sorbate | 1VPU26JZZ4 | IACT |
| water | 059QF0KO0R | IACT |
| sorbitan monostearate | NVZ4I0H58X | IACT |
| stearyl alcohol | 2KR89I4H1Y | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fb486a57-6476-46cf-a3ed-642fff2b8917 | ffd80bad-3a32-4f74-bebb-2afe8d1f048f | 2018-08-23 | Warnings | ffd80bad-3a32-4f74-bebb-2afe8d1f048f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
