TerraFreeze Pain Relief

MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE TOPICAL HUMAN OTC DRUG

TerraFreeze Pain Relief is an FDA drug label for the active ingredient MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE manufactured by Beyond Derma, 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 20231111.

Generic name
MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE
Manufacturer
Beyond Derma, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
71805-855
Application
M017
Label effective
20231111

About this product

TerraFreeze Pain Relief is an FDA-registered drug product whose active ingredient is MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE. It is labelled by Beyond Derma, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71805-855, application M017, label effective 20231111. 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,HISTAMINE DIHYDROCHLORIDE are most often described in connection with: temporary relief, minor aches, joints associated, arhritis simple, backache sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Menthol 10.00% Methyl Salicylate 10.00% Histamine DHCl 0.050% Purpose Topical Analgesic

Indications & Usage

Uses: For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Dosage & Administration

Directions Apply to affected area 3-4 times daily. Adults and children two-years of age or older: Consult a physician Children under two-years of age:

Warnings

Warnings: For External use only Keep out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. When using this product Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water Do not bandage tightly Stop use and ask a doctor if: Rash appears If symptoms persist for more than seven days, discontinue use and consult physician If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.

Frequently asked questions

What is TerraFreeze Pain Relief used for?
Uses: For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Who makes TerraFreeze Pain Relief?
Beyond Derma, LLC is the labeler of record for TerraFreeze Pain Relief.

What form does TerraFreeze 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 TerraFreeze 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.

Has TerraFreeze 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.