HYDROCORTISONE OINTMENT USP, 0.5%
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2017-08-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:12:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient:
Hydrocortisone 5 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
mineral oil and white petrolatum
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
W5157B
R12/11
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0016-31 | GM - Gram | 0168-0016 | 8c507401-727f-4009-9c1b-bc8b0f36b72d | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- HYDROCORTISONE
- PETROLATUM
- MINERAL OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-1844 | 68071-1844-5 |
| 0168-0016 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a36f2f4d-ddc7-bc61-e053-2995a90a25c2 | 575c4e1f-b017-c017-e053-2a91aa0acd3e | 2020-04-16 | Warnings | 575c4e1f-b017-c017-e053-2a91aa0acd3e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
