FDA Label for Major Arthritis Pain Relief Patch
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- FOR EXTERNAL USE ONLY
- DO NOT USE:
- WHEN USING THIS PRODUCT
- STOP USE AND CONSULT A DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- USES
- DIRECTIONS
- INACTIVE INGREDIENTS
- INDICATION AND USAGE
- IF PREGNANT OR BREASTFEEDING
- ASK A DOCTOR BEFORE USE
- QUESTIONS OR COMMENTS?
- OTHER INFORMATION
- MAJOR ARTHRITIS PAIN RELIEF PATCH LABEL
Major Arthritis Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.