Petroleum Jelly

Petroleum Jelly is an FDA-registered drug product whose active ingredient is PETROLATUM. It is labelled by Walgreens taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0363-0721, application M016, label effective 20260804. It is one of 38 FDA drug label records sharing the active ingredient PETROLATUM. 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.

When using this product do not get into eyes

Directions apply as needed

Warnings For external use only

FDA lists 38 drug label records with PETROLATUM 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Petroleum Jelly used for?
When using this product do not get into eyes

Who makes Petroleum Jelly?
Walgreens is the labeler of record for Petroleum Jelly. 38 FDA label records share the active ingredient PETROLATUM, 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 Petroleum Jelly 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 Petroleum Jelly 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 PETROLATUM?
Yes. 38 FDA drug label records list PETROLATUM 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 Petroleum Jelly been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.