• 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
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, con...
• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date
Hydrocortisone USP 1%
Anti-itch
• 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
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, unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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.
Paraffin wax, Micro wax, Light liquid paraffin
• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date
1 844 500-2729 between 9 am and 4 pm EST, Monday to Friday.
MAXIMUM STRENGTH ANTI-ITCH OINTMENT
Temporary Relief the Discomfort of itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites
Compared to the active ingredient in Cortizone 10
Distributed by.
ARU PHARMA INC.
MOUNT VERNON, NY 10552
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70403-922-30 | 2023-05-15 | C162847 | 48780-1 | ab0e2407-3017-f274-e053-dbdaa90a6471 | QPACK HYDROCORTISONE OINTMENT 1% |
| 70403-922-30 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3017-f274-e053-dbdaa90a6471 | QPACK HYDROCORTISONE OINTMENT 1% |
| 70403-922-30 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3017-f274-e053-dbdaa90a6471 | QPACK HYDROCORTISONE OINTMENT 1% |
| 70403-922-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3017-f274-e053-dbdaa90a6471 | QPACK HYDROCORTISONE OINTMENT 1% |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70403-922-30 | GM - Gram | 70403-922 | 1376ab2f-fb77-4917-a279-e9bab68d39c1 | 1 | 2020-01-03 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70403-922 | 70403-922-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| PARAFFIN | I9O0E3H2ZE | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
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 |
|---|---|---|---|---|---|---|
| fb4fc19b-b329-466b-828f-86a7593b44a5 | 298e3aee-a26b-4a72-a4ca-6848689130ab | 2023-05-15 | Warnings | fb4fc19b-b329-466b-828f-86a7593b44a5 298e3aee-a26b-4a72-a4ca-6848689130ab |
Adverse event summaries are temporarily unavailable. Other product information remains available.
