Herbal Balm

Herbal Balm is an FDA-registered drug product whose active ingredient is METHYL SALICYLATE, MENTHOL AND. It is labelled by Big 5 Nutrition LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82198-0007, application M017, label effective 20231120. 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 METHYL SALICYLATE, MENTHOL AND are most often described in connection with: temporary relief, minor aches, pains muscles, joints due, arthritis strains, bruises sprains, simple backache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For temporary relief of minor aches and pains of muscles and joints due to: arthritis strains bruises sprains simple backache

Directions Apply to the affected area. Rub well on affected area. Repeat 2 times daily. Children under 2 years of age: Do not use or consult a doctor.

Warnings For external use only Do not use on wounds irritated or damaged skin sensative skin with a heating pad if pregnant with, or as the same time as, other external analgesic products if allergic to aspirin or salicylates if allergic to any ingredients of this prodcut When using this product avoid contact with eyes do not bandage tightly do not apply to wounds or damaged skin do not use 1 hour before or after bathing Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops redness is present side effects occur If pregnant , ask a health professional before use. Keep out of reach of children to avoid accidental poisoning In case of overdose , get medical help or contact a Poison Control Center right away. Do not use otherwise than as directed.

What is Herbal Balm used for?
Uses For temporary relief of minor aches and pains of muscles and joints due to: arthritis strains bruises sprains simple backache

Who makes Herbal Balm?
Big 5 Nutrition LLC is the labeler of record for Herbal Balm.

What form does Herbal Balm 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 Herbal Balm 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.

Has Herbal Balm 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.