Major Arthritis Pain Relief Patch
Major Arthritis Pain Relief Patch
f91151b1-ed71-4910-e053-6394a90a2559
HUMAN OTC DRUG LABEL
Aug 12, 2025
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
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Major Arthritis Pain Relief Patch Label
OTC - QUESTIONS SECTION
Questions or Comments?
Toll Free 1-866-326-1313
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Active Ingredients Purpose
Menthol 3.0% .......................Topical Analgesic
Methyl Salicylate 10.0% NSAID: nonsteroidal anti-inflammatory drug .......Topical Analgesic
OTHER SAFETY INFORMATION
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
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
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
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
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
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
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
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
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
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