Petrocort Antipruritic Lip 21

Petrocort Antipruritic Lip 21 is an FDA-registered drug product whose active ingredient is HYDROCORTISONE. It is labelled by Clinical Formula LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51822-021, application M017, label effective 20231215. 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: children years, temporary relief, minor skin, rashes help, temporarily protect, chafed chapped, cracked windburned, sunburned lips. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES: Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

DIRECTIONS: Apply to lips 1-3 times daily or use as directed by physician. For use on children under 5 years of age, consult a physician.

WARNINGS: For external use only. If condition worsens, does not improve, or symptoms persist for more than 7 days or clear up and reoccur again within a few days, discontinue use and consult a physician. Keep from heat. Keep out of reach of children.

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 Petrocort Antipruritic Lip 21 used for?
USES: Adults and children 5 years and over: For the temporary relief of minor skin irritations and rashes. Help prevent and temporarily protect chafed, chapped, cracked, windburned or sunburned lips.

Who makes Petrocort Antipruritic Lip 21?
Clinical Formula LLC is the labeler of record for Petrocort Antipruritic Lip 21. 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 Petrocort Antipruritic Lip 21 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 Petrocort Antipruritic Lip 21 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 Petrocort Antipruritic Lip 21 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.