temporary relieves itching associated with minor skin irritations, inflammation and rashes due to: ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps ● detergents ● cosmetics ● jewelry ● external genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor
● 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 a soft cloth before applying. ● adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily. ● children under 12 years of age: Do not use, consult a doctor.
● to open: unscrew cap and pull tab to remove foil seal ● if seal has been broken, do not use this product. Return product to the Store where you bought it ● store at controlled room temperature 15°-30°C ( 59 °- 86 °F) see carton or tube crimp for lot number and expiration date
www.trifecta-pharma.comHydrocortisone 1%
Anti-Itch
If swallowed, get medical help or contact a Poison Control Center immediately.
temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
● detergents ● cosmetics ● jewelry ● external genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
● for external use only ● avoid contact with the eyes
● do not put this product into the rectum by using fingers or any mechanical device or applicator
● Stop using this product and ask a doctor ● in case of bleeding
● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
● before you begin using any other hydrocortisone product
Do not use this product and ask a doctor
● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age
For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor
● in case of bleeding, consult a doctor promptly
● do not put this product into the rectum by using fingers or any mechanical device or applicator
● children under 12 years of age: consult a doctor
Before using any medication, read all label directions. Keep this carton. It contains important information.
● 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 a soft cloth before applying.
● adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
● children under 12 years of age: Do not use, consult a doctor.
Light Mineral Oil, Petrolatum
● to open: unscrew cap and pull tab to remove foil seal
● if seal has been broken, do not use this product. Return product to the Store where you bought it
● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)
see carton or tube crimp for lot number and expiration date
MAXIMUM STRENGTH
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
Product of PRC
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-017-05 | Hydrocortisone 1% | 1 in 1 BOX | OINTMENT | 1 | 9 | |
| 69396-017-05 | Hydrocortisone 1% | 15 g in 1 TUBE | OINTMENT | 15 | 9 | |
| 69396-017-20 | Hydrocortisone 1% | 1 in 1 BOX | OINTMENT | 1 | 9 | |
| 69396-017-20 | Hydrocortisone 1% | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69396-017 | 69396-017-20, 69396-017-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Hydrocortisone 1% | HYDROCORTISONE | Trifecta Pharmaceuticals Usa Llc | 9a23c992-2df9-4bef-9409-47805eecfacd | 2024-12-18 | Warnings | 69396-017-20 69396-017-05 69396-017 69396001705 69396001720 298f35e6-52c9-95c9-e063-6294a90a1f41 9a23c992-2df9-4bef-9409-47805eecfacd |
Adverse event summaries are temporarily unavailable. Other product information remains available.