Pramosone

Pramosone is an FDA-registered drug product whose active ingredient is HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE. It is labelled by Sebela Pharmaceuticals Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 54766-777, label effective 20260529. It is one of 2 FDA drug label records sharing the active ingredient HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE. 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.

Across FDA labelling, products containing HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE are most often described in connection with: usage topical, pruritic manifestations, corticosteroid-responsive dermatoses. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Foliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

FDA lists 2 drug label records with HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE 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.

What is Pramosone used for?
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Who makes Pramosone?
Sebela Pharmaceuticals Inc. is the labeler of record for Pramosone. 2 FDA label records share the active ingredient HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE, 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 Pramosone 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 Pramosone prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE?
Yes. 2 FDA drug label records list HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE 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 Pramosone 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.