for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine 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 affected area not more than 3 to 4 times daily. Children under 2 years of age * do not use, consult a doctor. For external anal itching - Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product. Children under 12 yea...
Storage temperature: not to exceed 30 o C (86 o F). Protect from freezing. Before using any medication, read all label directions. Keep carton, it contains important information.
Hydrocortisone, USP 0.5%
Anti-itch
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, 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
for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.
avoid contact with the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator
symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly
If swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 2 years of age and older * apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age * do not use, consult a doctor.
For external anal itching - Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.
Children under 12 years of age: consult a doctor.
Storage temperature: not to exceed 30oC (86oF). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.
benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0639-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e56f-a426-e053-dadaa90af4c2 | f872781e-6571-4295-8ab6-1455f0b823df |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0639-01 | Regular Strength Hydrocortisone Cream | 56 g in 1 TUBE | CREAM | 56 | 9 | |
| 0363-0639-03 | Regular Strength Hydrocortisone Cream | 1 in 1 CARTON | CREAM | 1 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0639 | 0363-0639-01, 0363-0639-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETYL PALMITATE | 5ZA2S6B08X | IACT |
| ISOSTEARYL NEOPENTANOATE | 411THY156Q | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| PEG-40 STEARATE | ECU18C66Q7 | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | 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 |
|---|---|---|---|---|---|---|
| f3e376d6-532f-4b3e-9730-77f6a5ac2ead | f872781e-6571-4295-8ab6-1455f0b823df | 2020-10-29 | Warnings | f3e376d6-532f-4b3e-9730-77f6a5ac2ead f872781e-6571-4295-8ab6-1455f0b823df |
Adverse event summaries are temporarily unavailable. Other product information remains available.