ZIMS MAX FREEZE PRO FORMULA

ZIMS MAX FREEZE PRO FORMULA is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by KOBAYASHI Healthcare International, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54273-008, application M017, label effective 20231116. 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 12 years of age and over spray affected area not more than 4 times daily no need to rub wash hands after each use with cold water Children under 12 years of age consult a doctor

Warnings For external use only Rare cases of burns have been reported with products of this type Flammable keep away from fire or flame and heated surfaces do not use near sparks or while smoking do not use in a small or confined space avoid long term storage above 104° F (40° C) do not puncture or incinerate. Contents under pressure. do not expose to temperature exceeding 119° F (48° C) Do not use if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device near face after expiration date When using this product may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes avoid inhalation Stop use and ask a doctor if burning sensation is painful and persistent condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, 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.

What is ZIMS MAX FREEZE PRO FORMULA 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 ZIMS MAX FREEZE PRO FORMULA?
KOBAYASHI Healthcare International, Inc. is the labeler of record for ZIMS MAX FREEZE PRO FORMULA. 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 ZIMS MAX FREEZE PRO FORMULA 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 ZIMS MAX FREEZE PRO FORMULA 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 ZIMS MAX FREEZE PRO FORMULA 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.