Leg Cramps

Leg Cramps is an FDA-registered drug product whose active ingredient is ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP. It is labelled by Hyland's Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54973-3270, label effective 20260830. It is one of 2 FDA drug label records sharing the active ingredient ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP. 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 ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP are most often described in connection with: helps temporarily, symptoms cramps, pains legs. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Helps temporarily relieve the symptoms of cramps and pains in legs and calves.

Directions Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

Warnings For external use only. Keep away from eyes. Do not use on open wounds. Stop use and ask a doctor if symptoms persist for more than 7 days or worsen. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children.

FDA lists 2 drug label records with ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP 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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Leg Cramps used for?
Uses Helps temporarily relieve the symptoms of cramps and pains in legs and calves.

Who makes Leg Cramps?
Hyland's Inc. is the labeler of record for Leg Cramps. 2 FDA label records share the active ingredient ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP, 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 Leg Cramps 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 Leg Cramps 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 ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP?
Yes. 2 FDA drug label records list ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP 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 Leg Cramps been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.