Salonpas pain relieving hot

CAPSAICIN, MENTHOL TOPICAL HUMAN OTC DRUG

Salonpas pain relieving hot is an FDA drug label for the active ingredient CAPSAICIN, MENTHOL manufactured by Hisamitsu Pharmaceutical Co., 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 20260707.

Generic name
CAPSAICIN, MENTHOL
Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
46581-871
Application
M017
Label effective
20260707

About this product

Salonpas pain relieving hot is an FDA-registered drug product whose active ingredient is CAPSAICIN, MENTHOL. It is labelled by Hisamitsu Pharmaceutical Co., Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 46581-871, application M017, label effective 20260707. It is one of 3 FDA drug label records sharing the active ingredient CAPSAICIN, MENTHOL. 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 CAPSAICIN, MENTHOL are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, simple backache, arthritis strains, bruises sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Capsicum extract 0.025% as Capsaicin Menthol 1.25%

Indications & Usage

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

Dosage & Administration

Directions Adults and children 12 years of age and over: clean and dry affected area remove film from patch and apply to the skin (see illustration) apply to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8 hour-application Children under 12 years of age: consult a doctor

Warnings

Warnings For external use only Do not use on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower Stop use and ask a doctor if skin reactions such as redness, itching, rash, excessive irritation, buring sensation, swelling or blistering occur conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

CAPSAICIN, MENTHOL

PURE EASE Joint Muscle lnstant Pain Relief

SERENU, INC. View label

PURE EASE Neur Cream Instant Deep Pain Relief

SERENU, INC. View label

How products containing CAPSAICIN, MENTHOL compare

FDA lists 3 drug label records with CAPSAICIN, MENTHOL 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
— — SERENU, INC. 2
— — Hisamitsu Pharmaceutical Co., Inc. 1
— — — —
— — — —
— — — —

Frequently asked questions

What is Salonpas pain relieving hot used for?
Uses For temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Who makes Salonpas pain relieving hot?
Hisamitsu Pharmaceutical Co., Inc. is the labeler of record for Salonpas pain relieving hot. 3 FDA label records share the active ingredient CAPSAICIN, MENTHOL, 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 Salonpas pain relieving hot 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 Salonpas pain relieving hot 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 CAPSAICIN, MENTHOL?
Yes. 3 FDA drug label records list CAPSAICIN, MENTHOL 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 Salonpas pain relieving hot 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.