OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Hydrocortisone 1%
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
for the temporary relief of itching associated with minor skin irritations and rashes due to:
Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor
Warnings
For external use only
Do not use in genital area if you have a vaginal discharge.
Consult a doctor, for the treatment of diaper rash. Ask a doctor.
When using this product
Stop use and ask a doctor if
condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For itching of skin irritation, inflammation, and rashes:
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: Ask a doctor
For external anal and genital itching, adults:
When practical, clean the affected area with mild soap and water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.
Other information
Inactive Ingredients
Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta
PRINCIPAL DISPLAY PANEL
HYDROCORTISONE ANTI-ITCH CREAM
NET WT 0.5 OZ. (14 g)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47046-157-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-80d8-a426-e053-dadaa90af4c2 | Hydrocortisone Anti-Itch Cream |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47046-157-01 | Hydrocortisone Anti-Itch | 14 g in 1 TUBE | CREAM | 14 | 1 | |
| 47046-157-02 | Hydrocortisone Anti-Itch | 1 in 1 BOX | CREAM | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 47046-157 | 47046-157-01, 47046-157-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| EDETATE SODIUM | MP1J8420LU | 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 |
|---|---|---|---|---|---|---|
| b659fc57-0a33-e029-e053-2995a90aa85b | b6599a77-37c1-deec-e053-2995a90abd0e | 2020-12-13 | Warnings | b659fc57-0a33-e029-e053-2995a90aa85b b6599a77-37c1-deec-e053-2995a90abd0e |
Adverse event summaries are temporarily unavailable. Other product information remains available.