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 for lot number and expiration date.
Hydrocortisone 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.
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
Inactive ingredients Light Mineral Oil, White Petrolatum
see carton or tube for lot number and expiration date.
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-003-20 | Hydrocortisone | 1 in 1 BOX | OINTMENT | 1 | 10 | |
| 69396-003-20 | Hydrocortisone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 10 | |
| 69396-003-33 | Hydrocortisone | 3 in 1 BOX | OINTMENT | 3 | 10 | |
| 69396-003-33 | Hydrocortisone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 10 | |
| 69396-003-44 | Hydrocortisone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 10 | |
| 69396-003-44 | Hydrocortisone | 4 in 1 BOX | OINTMENT | 4 | 10 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69396-003-20 | GM - Gram | 69396-003 | d236d437-c189-448a-92c8-0549398351c0 | 1 | 2018-05-09 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | 4 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 4 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 4 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69396-003 | 69396-003-20, 69396-003-44, 69396-003-33 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg |
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 | HYDROCORTISONE | TRIFECTA PHARMACEUTICALS USA LLC | 2999fecb-cb15-4023-ade4-ab5822b094d5 | 2024-02-29 | Warnings | 69396-003-33 69396-003-44 69396-003-20 69396-003 69396000344 69396000333 69396000320 1286af63-33fc-5b93-e063-6294a90a9717 2999fecb-cb15-4023-ade4-ab5822b094d5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.