Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING is an FDA drug label for the active ingredient MENTHOL, METHYL SALICYLATE manufactured by Rexall Sundown, LLC 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 20231110.
- Generic name
- MENTHOL, METHYL SALICYLATE
- Manufacturer
- Rexall Sundown, LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 59118-837
- Application
- M017
- Label effective
- 20231110
About this product
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING is an FDA-registered drug product whose active ingredient is MENTHOL, METHYL SALICYLATE. It is labelled by Rexall Sundown, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59118-837, application M017, label effective 20231110. It is one of 5 FDA drug label records sharing the active ingredient MENTHOL, METHYL SALICYLATE. 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, METHYL SALICYLATE are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, arthritis simple, backache 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 For the temporary relief of minor aches and pains of muscles and joints associated with: - arthritis - simple backache - strains - bruises - sprains
Dosage & Administration
Directions Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. For best results apply daily or as directed by a physician After applying, wash hands with soap and water. Children under 12 years of age: consult a doctor.
Warnings
Warnings For external use only. When using this product Use only as directed Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged, broken or irritated skin Do not bandage tightly or apply local heat (such as heating patches) to the area of use Discontinue use and consult a doctor if Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Irritation develops/excessive irritation occurs If pregnant or breastfeeding ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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View labelHow products containing MENTHOL, METHYL SALICYLATE compare
FDA lists 5 drug label records with MENTHOL, METHYL SALICYLATE 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 |
|---|---|---|---|
| — | — | Big 5 Nutrition LLC | 4 |
| — | — | Rexall Sundown, LLC | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Frequently asked questions
What is Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING used for?
Uses For the temporary relief of minor aches and pains of muscles and joints associated with: - arthritis - simple backache - strains - bruises - sprains
Who makes Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING?
Rexall Sundown, LLC is the labeler of record for Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING. 5 FDA label records share the active ingredient MENTHOL, METHYL SALICYLATE, 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 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING 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 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING 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, METHYL SALICYLATE?
Yes. 5 FDA drug label records list MENTHOL, METHYL SALICYLATE 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 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING 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.