Uses
For the temporary relief of itching associated with minor skin irritations and rashes due to
■eczema ■insect bites ■poison ivy ■poison oak ■poison sumac
■soaps ■detergents ■cosmetic ■jewelry
■seborrheic determatis ■psoriasis ■external anal itching
Other uses of this product should be only under the advice and supervision of a doctor.
Warnings
For external use only
Do not use for the treatment of diaper rash. Consult a doctor.
When using this product
■avoid contact with the eyes
■do not exceed the recommended daily dosage unless directed by a doctor (for external anal itching)
■consult a doctor promptly in case of bleeding (for external anal itching)
■do not put this product into the rectum by using fingers or any mechanical device or applicator (for external anal itching)
Stop use of this or any other hydrocortisone product and ask a doctor if
■condition worsens ■symptoms persist for more than 7 days.
■symptoms clear up and occur again within a few days.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■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
(When used for external anal itching)
■adults and children 12 years of age and older: 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 soft cloth before application of this product
■children under 12 years of age: consult a doctor
Other information keep tube tightly closed
Inactive ingredients fragrance, glyceryl monostearate, light mineral oil, white petrolatum, zinc oxide
Active ingredient
Hydrocortisone acetate 1.0%
Purpose Antipruritic (anti-itch)
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49873-703-01 | Poli-A | 20 g in 1 TUBE | OINTMENT | 20 | 8 | |
| 49873-703-01 | Poli-A | 1 in 1 CARTON | OINTMENT | 1 | 8 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| hydrocortisone acetate | ACTIVE INGREDIENT | 3X7931PO74 | 5 | |
| hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | 5 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 5 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 5 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 5 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49873-703 | 49873-703-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| ZINC OXIDE | SOI2LOH54Z | IACT |
| HYDROCORTISONE ACETATE | 3X7931PO74 | 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 |
|---|---|---|---|---|---|---|
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | LOTION / TOPICAL | 16 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | LOTION / TOPICAL | 16 %w/w |
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 |
|---|---|---|---|---|---|---|
| Poli-A | HYDROCORTISONE ACETATE | Sato Pharmaceutical Co., Ltd. | e27a3840-d9de-4bd0-ad75-8a151bd12b83 | 2023-11-28 | Warnings | 49873-703-01 49873-703 49873070301 0b404611-4b3b-500a-e063-6394a90a62b3 e27a3840-d9de-4bd0-ad75-8a151bd12b83 |
Adverse event summaries are temporarily unavailable. Other product information remains available.