MAJOR ARTHRITIS PAIN RELIEF PATCH- menthol, methyl salicylate patch

Major Arthritis Pain Relief Patch by

Drug Labeling and Warnings

Major Arthritis Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients Purpose

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

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

For External Use Only

Allergy alert:If prone to allergic reaction from asprin or salicylates, consult a doctor before use Stomach 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

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

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

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

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

Uses

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

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

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.

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

Questions or Comments?

Toll Free 1-866-326-1313

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

Major Arthritis Pain Relief Patch Label

INGREDIENTS AND APPEARANCE

MAJOR ARTHRITIS PAIN RELIEF PATCH 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7342
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7342-33	5 in 1 BOX	04/01/2023
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 0904-7342-01	1 in 1 POUCH	05/01/2023
2		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2023

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(0904-7342)