MedPath

Major Arthritis Pain Relief Patch

Major Arthritis Pain Relief Patch

Approved
Approval ID

f91151b1-ed71-4910-e053-6394a90a2559

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MENTHOL, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-7342
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL, METHYL SALICYLATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (6)

HYDROGENATED C6-20 POLYOLEFIN (100 CST)Inactive
Code: 39EYQ1W9RB
Classification: IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)Inactive
Code: 255PIF62MS
Classification: IACT
LIQUID PETROLEUMInactive
Code: 6ZAE7X688J
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)Inactive
Code: 5Z4DPO246A
Classification: IACT
MENTHOLActive
Quantity: 3 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 10 g in 100 g
Code: LAV5U5022Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Major Arthritis Pain Relief Patch Label

image description

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/1/2023

Questions or Comments?

Toll Free 1-866-326-1313

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/1/2023

Active Ingredients

Active Ingredients Purpose

Menthol 3.0% .......................Topical Analgesic

Methyl Salicylate 10.0% NSAID: nonsteroidal anti-inflammatory drug .......Topical Analgesic

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/1/2023

Other information

■ store at 20-25°C (68-77°F) ■ avoid storing in direct sunlight ■ protect product from
excessive moisture ■ some individuals may not experience pain relief until several hours after applying the patch

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2023

For External Use Only

Allergy alert:If prone to allergic reaction from asprin or salicylates, consult a doctor before useStomach bleeding
**warning:**This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if
you: ■ are age 60 or older ■ have stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or
steroid drug ■ take other drugs containing an NSAID (asprin, ibuprofen, naproxen, or others) ■ have 3 or more
alcoholic drinks every day while using this product ■ take (apply) more or for longer time than directed

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 4/1/2023

Do not use:

on the face or rashes ■ on wounds or damaged skin ■ if allergic to aspirin or other NSAIDs ■ with a
heating pad ■ when sweating (such as from exercise or heat) ■ any patch from a pouch that has be open for 14 or
more days ■ right before or after heart surgery

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 4/1/2023

When using this product

■ use only as directed ■ wash hands after applying or removing patch ■ avoid contact
with eyes, If eye contact occurs, rinse thoroughly with water ■ Dispose of used patch away from children and pets.
Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews
or ingests the patch ■ the risk of heart attach or stroke may increase if you use more than directed or for longer
than directed

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 4/1/2023

Stop use and consult a doctor

■ stomach pain or upset gets worse or lasts ■ you feel faint, vomit blood, or have
bloody or black stools. These are a sign of stomach bleeding ■ rash, itchy or skin irritation develops ■ condition
worsens ■ symptoms last for more than 3 days ■ symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/1/2023

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Packaging is not child-resistant

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/1/2023

Uses

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2023

Directions

**Adults 18 years of age and over: ■**only use 1 patch at a time ■ clean and dry affected area.
■ remove patch from backing film and apply to skin (see illustration) ■ leave patch in place for up to 8 to 12 hours
■ if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours ■ remove
used patch from the skin before a new one is applied ■ do not use more than 2 patches per day ■ do not use for
more than 3 days in row ■ properly discard patch after single use ■ reseal pouch after opening.
**Children under 18 years of age:**do not use this product.

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
■ strains ■ sprains ■ simple backache ■ arthritis ■ bruises

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 4/1/2023

If pregnant or breastfeeding

ask a doctor before use while breast-feeding and during the first 6 months of
pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child
or complications during delivery.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 4/1/2023

Ask a doctor before use

■ you are allergic to topical products ■ the stomach bleeding warning applies to you
■ you are taking a diuretic ■ you have high blood pressure, heart disease, or kidney disease

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.