For temporary relief of 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 feminine genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor. For External and anal itching: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. Children: under 12 y...
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
www.trifecta-pharma.comHydrocortisone 1%
Anti-Itch
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
For temporary relief of 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 feminine genital 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:
For the treatment of a diaper rash, consult with doctor
For external genital itching if you have a vaginal discharge, consult doctor
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult a doctor.
For External and anal itching:
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children: under 12 years of age with external anal itching: consult a doctor.
Ethylparaben, glycerin, glyceryll monostearate, mineral oil, stearyl alcohol, petrolatum, purified water, sodium lauryl sulfate
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
Product of PRC
This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone - 10®
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-055-01 | Hydrocortisone 1% | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 69396-055-01 | Hydrocortisone 1% | 1 in 1 BOX | CREAM | 1 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69396-055 | 69396-055-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | 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 | 9ef5a3b2-c36f-162f-e053-2995a90ae2b0 | 2024-12-18 | Warnings | 69396-055-01 69396-055 69396005501 299056d9-3089-2129-e063-6394a90a804a 9ef5a3b2-c36f-162f-e053-2995a90ae2b0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.