Freskaro Calamine Plus

Freskaro Calamine Plus is an FDA-registered drug product whose active ingredient is ZINC OXIDE LOTION. It is labelled by Pharma Nobis, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82645-420, application M016, label effective 20260415. It is one of 3 FDA drug label records sharing the active ingredient ZINC OXIDE LOTION. 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 ZINC OXIDE LOTION are most often described in connection with: temporarily relieves, itching poison, minor skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: do not use, consult a doctor.

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes,

FDA lists 3 drug label records with ZINC OXIDE LOTION 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 Freskaro Calamine Plus used for?
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

Who makes Freskaro Calamine Plus?
Pharma Nobis, LLC is the labeler of record for Freskaro Calamine Plus. 3 FDA label records share the active ingredient ZINC OXIDE LOTION, 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 Freskaro Calamine Plus 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 Freskaro Calamine Plus 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 ZINC OXIDE LOTION?
Yes. 3 FDA drug label records list ZINC OXIDE LOTION 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 Freskaro Calamine Plus 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.