AEROSOOTHE

AEROSOOTHE is an FDA-registered drug product whose active ingredient is HYDROCORTISONE. It is labelled by Aero Healthcare US LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 55305-136, application M017, label effective 20260724. It is one of 81 FDA drug label records sharing the active ingredient HYDROCORTISONE. 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 are most often described in connection with: temporary relief, itching associated, minor skin, external genital, supervision doctor. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for temporary relief of itching associated with minor skin irritations and rashes for external genital, feminine, and anal itching other uses of this product should be only under the advice and supervision of a doctor

Directions For itching or 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 of age: do not use unless directed by a doctor For external anal and genital itching, Adults: when practical, clean the affected area with mild soap and warm 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

Warnings For external use only.

FDA lists 81 drug label records with HYDROCORTISONE 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 AEROSOOTHE used for?
Uses for temporary relief of itching associated with minor skin irritations and rashes for external genital, feminine, and anal itching other uses of this product should be only under the advice and supervision of a doctor

Who makes AEROSOOTHE?
Aero Healthcare US LLC is the labeler of record for AEROSOOTHE. 81 FDA label records share the active ingredient HYDROCORTISONE, 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 AEROSOOTHE 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 AEROSOOTHE 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?
Yes. 81 FDA drug label records list HYDROCORTISONE 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 AEROSOOTHE 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.