Traulevium Pain Relief Gel

ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM. TOPICAL HUMAN OTC DRUG

Traulevium Pain Relief Gel is an FDA drug label for the active ingredient ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM. manufactured by Medical Technology Products, Inc. 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 20211229.

Generic name: ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.
Manufacturer: Medical Technology Products, Inc.
Product type: HUMAN OTC DRUG
Route: TOPICAL
Dosage form: N/A
NDC: 70857-004
Application: N/A
Label effective: 20211229

About this product

Traulevium Pain Relief Gel is an FDA-registered drug product whose active ingredient is ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.. It is labelled by Medical Technology Products, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70857-004, label effective 20211229. 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 ARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM. are most often described in connection with: temporary relief, joint pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENTS Active ingredients (HPUS*) Purpose** Each 100 g of gel contains: Arnica Montana, Radix 3X 1500 mg Reduces joint & back pain Calendula Officinalis MT (N) 450 mg Relieves pain Hamamelis Virginiana MT (N) 450 mg Relieves joint & muscle soreness Echinacea MT (N) 150 mg Relieves pain Echinacea Purpurea MT (N) 150 mg Relieves pain Chamomilla MT (N) 150 mg Soothing pain relief Symphytum Officinale 4X (Final concentration 6X) 100 mg Relieves joint pain Bellis Perennis MT (M) 100 mg Relieves joint & muscle soreness Hypericum Perforatum 6X 90 mg Relieves pain Millefolium MT (N) 90 mg Relieves pain Aconitum Napellus 1X (Final concentration 4X) 50 mg Reduces joint & back pain Belladonna 1X 50 mg Reduces back pain Mercurius Solubilis 6X 40 mg Reduces joint & back pain Hepar Sulphuris Calcareum 6X 25 mg Relieves pain

Indications & Usage

USES Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Dosage & Administration

DIRECTIONS Adults and children 4 years and older Apply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. Children under 4 Consult your healthcare provider.

Warnings

WARNINGS Warnings For external use only. Do not apply over open wounds or broken skin. If symptoms worsen or persist for more than a week, or if a rash develops, a healthcare provider should be consulted. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traulevium or any of its ingredients exists. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, consult a healthcare provider before use. Keep out of the reach of children.

Frequently asked questions

What is Traulevium Pain Relief Gel used for?
USES Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Who makes Traulevium Pain Relief Gel?
Medical Technology Products, Inc. is the labeler of record for Traulevium Pain Relief Gel.

What form does Traulevium Pain Relief Gel 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 Traulevium Pain Relief Gel 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 Traulevium Pain Relief Gel 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.