SMOOTH GATOR 60-second Pain Relief

SMOOTH GATOR 60-second Pain Relief is an FDA-registered drug product whose active ingredient is CAMPHOR (SYNTHETIC), MENTHOL. It is labelled by Smooth Gator LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70673-298, application M017, label effective 20231110. It is one of 4 FDA drug label records sharing the active ingredient CAMPHOR (SYNTHETIC), 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 CAMPHOR (SYNTHETIC), MENTHOL are most often described in connection with: temporary relief, minor aches, joints associated, arthritis simple, backache sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions: Adults and children two-years of age or older: Children under two-year of age: consult a physician Apply to affected area not more than three to four times daily.

Warnings: For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly.

FDA lists 4 drug label records with CAMPHOR (SYNTHETIC), 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 SMOOTH GATOR 60-second Pain Relief used for?
Indications: For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Who makes SMOOTH GATOR 60-second Pain Relief?
Smooth Gator LLC is the labeler of record for SMOOTH GATOR 60-second Pain Relief. 4 FDA label records share the active ingredient CAMPHOR (SYNTHETIC), 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 SMOOTH GATOR 60-second Pain Relief 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 SMOOTH GATOR 60-second Pain Relief 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 CAMPHOR (SYNTHETIC), MENTHOL?
Yes. 4 FDA drug label records list CAMPHOR (SYNTHETIC), 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 SMOOTH GATOR 60-second Pain Relief 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.