Major Arthritis Pain Relief Patch

Major Arthritis Pain Relief Patch
SPL v9
SPL
SPL Set ID f91151b1-ed71-4910-e053-6394a90a2559
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Salicylic Acid (10 g)
Inactive Ingredients
Hydrogenated C6-20 Polyolefin (100 Cst) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/acrylamide Copolymer (mw 500000)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-04-01 Until 2026-04-25

Description

Active Ingredients Purpose Menthol 3.0% .......................Topical Analgesic Methyl Salicylate 10.0% NSAID: nonsteroidal anti-inflammatory drug .......Topical Analgesic


Medication Information

Description

Active Ingredients Purpose Menthol 3.0% .......................Topical Analgesic Methyl Salicylate 10.0% NSAID: nonsteroidal anti-inflammatory drug .......Topical Analgesic

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.

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

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

Active Ingredients

Active Ingredients Purpose

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

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

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

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

Questions Or Comments?

Toll Free 1-866-326-1313

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

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

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.

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

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

Major Arthritis Pain Relief Patch Label


Structured Label Content

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.

Do Not Use: (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

Other 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

Active Ingredients

Active Ingredients Purpose

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

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

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

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

Questions Or Comments? (Questions or Comments?)

Toll Free 1-866-326-1313

Ask A Doctor Before Use (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

When Using This Product (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

If Pregnant Or Breastfeeding (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.

Keep Out of Reach of Children (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

Stop Use and Consult A Doctor (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

Major Arthritis Pain Relief Patch Label


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