FDA Label for Methyl Salicylate
View Indications, Usage & Precautions
Methyl Salicylate Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacure, Inc.. 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 Ingredient Purpose
Methyl Salicylate 10% (NSAID: Nonsteroidal anti-inflammatory drug) Topical Analgesic
Uses
Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:
• strains • sprains • simple backache • arthritis • bruises
Warnings
For external use only
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 had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product • take more or for a 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 been open for 14 or more days • right before or after heart surgery
Ask a doctor before use if
• you are allergic to topical products • the stomach bleeding warning applies to you
• you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic
When using this product
• wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
• stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools
These are signs of stomach bleeding. • rash, itching or skin irritation develops
• condition worsens
• symptoms last for more than 3 days • symptoms clear up and occur again within a few days
If pregnant or breast-feeding,
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 put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.
Directions
Adults 18 years and older:
• Clean and dry affected area • Only use one patch at a time
• Remove patch from backing film and apply to skin
• Apply one patch to the affected area and leave 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
• Do not use more than 2 patches per day • Do not use for more than 3 days in a row
• The used patch should be removed from the skin when a new one is applied
• Children under 18 years of age: do not use: this product has not been shown to work in children
Inactive Ingredients
Adhesive, myrrh gum, zinc oxide.
Other Information
• Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight
•Protect product from excessive moisture
•Some individuals may not experience pain relief until several hours after applying the patch
Product Label
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