DIRT Pain Relieving Gel

DIRT Pain Relieving Gel is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by PURIVITAE, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83067-363, application M017, label effective 20231106. It is one of 193 FDA drug label records sharing the active ingredient MENTHOL. 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 MENTHOL are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, arthritis simple, strains bruises. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses: For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Directions: Adults and children over 12 years of age: Children 12 years or younger: ask a doctor apply generously to affected areas rub into affected area until absorbed into the skin repeat as necessary, but no more than 4 times daily

Warnings: For external use only Do not use on damaged or brokin skin. When using this product Avoid contact with the eyes. Do not bandage tightly. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away If pregnant or breast-feeding, ask a health professional before use

FDA lists 193 drug label records with MENTHOL 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 DIRT Pain Relieving Gel used for?
Uses: For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Who makes DIRT Pain Relieving Gel?
PURIVITAE, LLC is the labeler of record for DIRT Pain Relieving Gel. 193 FDA label records share the active ingredient MENTHOL, 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 DIRT Pain Relieving Gel 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 DIRT Pain Relieving Gel 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 MENTHOL?
Yes. 193 FDA drug label records list MENTHOL 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 DIRT Pain Relieving Gel 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.