Icy Hot Medicated, Back

Icy Hot Medicated, Back is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Lead Chemical Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 62168-0853, application 505G(a)(3), label effective 20260630. 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: single patch, pouch temporarily, relieves minor, pains muscles, joints associated, arthritis simple, backache strains, sprains bruises. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses – Single Patch Pouch temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Directions – Single Patch Pouch adults and children 12 years of age and older: • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area • apply to affected area not more than 3 to 4 times daily • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. children under 12 years of age: ask a doctor

Warnings – Single Patch Pouch For external use only Do not use – Single Patch Pouch • on wounds or on irritated or damaged skin • with a heating pad When using this product – Single Patch Pouch • use only as directed • do not bandage tightly • avoid contact with eyes and mucous membranes • do not expose the area to local heat or to direct sunlight • rare cases of serious burns have been reported with products of this type • a transient burning sensation may occur upon application but generally disappears in several days • avoid applying into skin folds Stop use and ask a doctor if – Single Patch Pouch • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • redness is present or excessive skin irritation occurs • you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, – Single Patch Pouch ask a health professional before use. Keep out of reach of children. – Single Patch Pouch 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 Icy Hot Medicated, Back used for?
Uses – Single Patch Pouch temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Who makes Icy Hot Medicated, Back?
Lead Chemical Co., Ltd. is the labeler of record for Icy Hot Medicated, Back. 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 Icy Hot Medicated, Back 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 Icy Hot Medicated, Back 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 Icy Hot Medicated, Back 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.