ActivICE

ActivICE is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Medline Industries, LP taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 53329-984, application M017, label effective 20260901. 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, simple backache, arthritis strains, bruises sprains. 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: simple backache arthritis strains bruises sprains

Directions Adults and children 2 years of age and older: apply directly onto affected area without the need to rub, massage or bandage repeat if necessary, but do not apply more than 3 to 4 times daily wash hands after use Children under 2 years of age: do not use, consult a doctor.

Warnings For external use only. Avoid contact with eyes. Flammable: keep away from fire or flame. When using this product use only as directed do not bandage tightly or use with heating pad do not apply to wounds or damaged skin Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days redness is present excessive irritation of the skin develops If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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 ActivICE used for?
Uses For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Who makes ActivICE?
Medline Industries, LP is the labeler of record for ActivICE. 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 ActivICE 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 ActivICE 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 ActivICE 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.