Publix Calamine Medicated

Publix Calamine Medicated is an FDA-registered drug product whose active ingredient is ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE. It is labelled by Publix taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 41415-420, application M016, label effective 20231218. It is one of 12 FDA drug label records sharing the active ingredient ZINC 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 ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, itching poison, ivy oak, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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

Warnings For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes. Ask a doctor before using on children 2 years of age.

FDA lists 12 drug label records with ZINC 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 Publix Calamine Medicated used for?
Uses Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

Who makes Publix Calamine Medicated?
Publix is the labeler of record for Publix Calamine Medicated. 12 FDA label records share the active ingredient ZINC 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 Publix Calamine Medicated 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 Publix Calamine Medicated 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 ACETATE AND PRAMOXINE HYDROCHLORIDE?
Yes. 12 FDA drug label records list ZINC 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 Publix Calamine Medicated 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.