OrthoNesic Pain Relieving Gel

MENTHOL, CAMPHOR CUTANEOUS HUMAN OTC DRUG

OrthoNesic Pain Relieving Gel is an FDA drug label for the active ingredient MENTHOL, CAMPHOR manufactured by Blaine Labs Inc. administered by CUTANEOUS. 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 20260701.

Generic name
MENTHOL, CAMPHOR
Manufacturer
Blaine Labs Inc.
Product type
HUMAN OTC DRUG
Route
CUTANEOUS
Dosage form
N/A
NDC
63347-420
Application
M017
Label effective
20260701

About this product

OrthoNesic Pain Relieving Gel is an FDA-registered drug product whose active ingredient is MENTHOL, CAMPHOR. It is labelled by Blaine Labs Inc. taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 63347-420, application M017, label effective 20260701. It is one of 10 FDA drug label records sharing the active ingredient MENTHOL, CAMPHOR. 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, CAMPHOR are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, arthritis bruises, strains simple. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

DRUG FACTS Active Ingredients Menthol - 3.5% Camphor - 3.0%

Indications & Usage

Uses ■ For temporary relief from minor aches and pains of muscles and joints associated with arthritis, bruises, strains simple backache, and sprains.

Dosage & Administration

Directions: Apply to the affected areas not more than 3 to 4 times daily. Rinse hands with cool water. ■ Adults and children 2 years and older: A pply to affected area not more than 3 to 4 times daily. ■ Children under 2 years of age: do not use, consult a physician.

Warnings

Warnings - for extrenal use only Do not use: ■ on wounds or damaged skin ■ with a heating pad When using this product : ■ avoid contact with eyes or mucous membranes ■ do not bandage tightly Stop use and ask a physician if : ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ excessive skin irritation develops.

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How products containing MENTHOL, CAMPHOR compare

FDA lists 10 drug label records with MENTHOL, CAMPHOR 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 formProductsManufacturerProducts
— — Blaine Labs Inc. 3
— — Active and Innovative 1
— — Active and Innovative Inc. 1
— — Indiana Botanic Gardens 1
— — Just Brands LLC 1

Frequently asked questions

What is OrthoNesic Pain Relieving Gel used for?
Uses ■ For temporary relief from minor aches and pains of muscles and joints associated with arthritis, bruises, strains simple backache, and sprains.

Who makes OrthoNesic Pain Relieving Gel?
Blaine Labs Inc. is the labeler of record for OrthoNesic Pain Relieving Gel. 10 FDA label records share the active ingredient MENTHOL, CAMPHOR, 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 OrthoNesic Pain Relieving Gel come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is OrthoNesic Pain Relieving 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.

Are there other products containing MENTHOL, CAMPHOR?
Yes. 10 FDA drug label records list MENTHOL, CAMPHOR 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 OrthoNesic Pain Relieving 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.