INACTIVE INGREDIENT SECTION
aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients
aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients
Active Ingredient
Hydrocortisone, USP 1%
Purpose
Anti-itch
- for temporary relief of itching associated with minor skin irritations,inflammation and rashes due to: Uses
- eczema -insect bites -poison ivy
-poison oak -poison sumac -soaps
-jewelry -detergents -cosmetics
-psoriasis -seborrheic dermatisis
-for external genital, feminine and anal itching
-other uses of this product should be only under the advice and supervision of a doctor
. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
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. Consult a doctor
Stop use and ask a doctor if
-symptoms last for more than 7 days
-the condition gets worse
-symptoms clear up and then occur again within a few days
-rectal bleeding occurs
When using this product
-avoid contact with eyes
-do not use more than directed unless directed by a doctor
-do not put this product into the rectum by using fingers or any other mechanical device or applicator
Directions
for itching of skin irritation, inflammation and rashes:
-adults and children 2 years of age and older: apply to the affected areanot more than 3 to 4 times dailt
-for children udner 2 years of age: ask a doctor
for external anal and genital itching, adults:
-clean the affected area with mild soap and warm water and rinse clean.
-dry the affected area before applying
-apply to the affected area not mroe than 3 to 4 times daily
-children under 12 years of age: ask a doctor
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 7 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 7 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 7 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 7 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55621-001-01 | Thera Plus | 28 g in 1 TUBE | CREAM | 28 | 7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | 4 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 4 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 4 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55621-001 | 55621-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 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 |
|---|---|---|---|---|---|---|
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | 55621-001-01 55621-001 55621000101 08849eb4-ae6b-8151-e063-6394a90a5a7e bcc99e5a-2403-46da-9c9d-8411fa4104e0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.