Poli-A
Poli-A is an FDA drug label for the active ingredient HYDROCORTISONE ACETATE manufactured by Sato Pharmaceutical Co., Ltd. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231128.
- Generic name
- HYDROCORTISONE ACETATE
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 49873-703
- Application
- M017
- Label effective
- 20231128
About this product
Poli-A is an FDA-registered drug product whose active ingredient is HYDROCORTISONE ACETATE. It is labelled by Sato Pharmaceutical Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 49873-703, application M017, label effective 20231128. It is one of 15 FDA drug label records sharing the active ingredient HYDROCORTISONE ACETATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing HYDROCORTISONE ACETATE are most often described in connection with: temporary relief, itching associated, minor skin, rashes due, eczema insect, bites poison, sumac soaps, detergents cosmetic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
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.
Dosage & Administration
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
Warnings
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.
More products with the same ingredient
HYDROCORTISONE ACETATEANUCORT-HC
View labelClaravie
View labelHYDROCORTISONE ACETATE
View labelHydrocortisone Acetate
View labelHydrocortisone Acetate
View labelHydrocortisone Acetate
View labelHydrocortisone Acetate
View labelHydrocortisone Acetate
View labelHow products containing HYDROCORTISONE ACETATE compare
FDA lists 15 drug label records with HYDROCORTISONE ACETATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Cosette Pharmaceuticals, Inc. | 2 |
| — | — | A-S Medication Solutions | 1 |
| — | — | AARNA USA INC. | 1 |
| — | — | APNAR PHARMA LP | 1 |
| — | — | Bentlin Products LLC | 1 |
Frequently asked questions
What is Poli-A used for?
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.
Who makes Poli-A?
Sato Pharmaceutical Co., Ltd. is the labeler of record for Poli-A. 15 FDA label records share the active ingredient HYDROCORTISONE ACETATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Poli-A come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Poli-A prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing HYDROCORTISONE ACETATE?
Yes. 15 FDA drug label records list HYDROCORTISONE ACETATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Poli-A been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.