First Degree Maximum Strength Burn

First Degree Maximum Strength Burn is an FDA-registered drug product whose active ingredient is PRAMOXINE HYDROCHLORIDE. It is labelled by Welmedix LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 24330-130, application part348, label effective 20170309. It is one of 8 FDA drug label records sharing the active ingredient 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 PRAMOXINE HYDROCHLORIDE are most often described in connection with: temporary relief, itching associated, minor burns, insect bites, cuts scrapes, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of pain and itching associated with: minor burns insect bites sunburns minor cuts scrapes minor skin irritations

Directions adults and children 2 years of age and older: clean the affected area apply to affected area not more than 3 to 4 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor

Warnings For external use only. Avoid contact with the eyes Do not use if you are allergic to any of the ingredients over large areas of the body Stop use and ask a doctor if condition worsens symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 8 drug label records with 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 First Degree Maximum Strength Burn used for?
Uses For the temporary relief of pain and itching associated with: minor burns insect bites sunburns minor cuts scrapes minor skin irritations

Who makes First Degree Maximum Strength Burn?
Welmedix LLC is the labeler of record for First Degree Maximum Strength Burn. 8 FDA label records share the active ingredient 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 First Degree Maximum Strength Burn 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 First Degree Maximum Strength Burn 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 PRAMOXINE HYDROCHLORIDE?
Yes. 8 FDA drug label records list 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 First Degree Maximum Strength Burn 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.