Label: MAJOR ARTHRITIS PAIN RELIEF PATCH- menthol, methyl salicylate patch

  • NDC Code(s): 0904-7342-01, 0904-7342-33
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

If you are a consumer or patient please visit this version.

  • 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

    labellabel

  • INGREDIENTS AND APPEARANCE
    MAJOR ARTHRITIS PAIN RELIEF PATCH 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7342
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7342-335 in 1 BOX04/01/2023
    19 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:0904-7342-011 in 1 POUCH05/01/2023
    29 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2023
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(0904-7342)