Overnight Cold Therapy Pain Relief
Overnight Cold Therapy Pain Relief is an FDA drug label for the active ingredient MENTHOL, UNSPECIFIED FORM manufactured by Walgreen Co. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231204.
- Generic name
- MENTHOL, UNSPECIFIED FORM
- Manufacturer
- Walgreen Co.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0363-0355
- Application
- M017
- Label effective
- 20231204
About this product
Overnight Cold Therapy Pain Relief is an FDA-registered drug product whose active ingredient is MENTHOL, UNSPECIFIED FORM. It is labelled by Walgreen Co. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0363-0355, application M017, label effective 20231204. It is one of 17 FDA drug label records sharing the active ingredient MENTHOL, UNSPECIFIED FORM. 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.
What it is used for
Across FDA labelling, products containing MENTHOL, UNSPECIFIED FORM are most often described in connection with: temporarily relieves, 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.
Active ingredients
Indications & Usage
Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Dosage & Administration
Directions adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water
Warnings
Warnings For external use only. Flammable: Keep away from excessive heat or open flame. When using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age 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.
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View labelHow products containing MENTHOL, UNSPECIFIED FORM compare
FDA lists 17 drug label records with MENTHOL, UNSPECIFIED FORM 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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Reckitt Benckiser LLC | 7 |
| — | — | KOBAYASHI Healthcare International, Inc. | 3 |
| — | — | Troy Manufacturing, Inc. | 2 |
| — | — | Beekeeper's Naturals USA Inc | 1 |
| — | — | Meriwether Skin LLC | 1 |
Frequently asked questions
What is Overnight Cold Therapy Pain Relief used for?
Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Who makes Overnight Cold Therapy Pain Relief?
Walgreen Co. is the labeler of record for Overnight Cold Therapy Pain Relief. 17 FDA label records share the active ingredient MENTHOL, UNSPECIFIED FORM, 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 Overnight Cold Therapy 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 Overnight Cold Therapy 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 MENTHOL, UNSPECIFIED FORM?
Yes. 17 FDA drug label records list MENTHOL, UNSPECIFIED FORM 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 Overnight Cold Therapy 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.