Label: METHYL SALICYLATE patch
- NDC Code(s): 79643-003-01
- Packager: PHARMACURE LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 3, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
-
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 directedDo 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 surgeryAsk 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 diureticWhen 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 directedStop 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 daysIf 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. - KEEP OUT OF REACH OF CHILDREN
-
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
- Other information
- Product label
-
INGREDIENTS AND APPEARANCE
METHYL SALICYLATE
methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79643-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 100 mg in 1000 mg Inactive Ingredients Ingredient Name Strength MYRRH (UNII: JC71GJ1F3L) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79643-003-01 2 in 1 BOX 02/17/2023 1 5 in 1 POUCH 1 1000 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/17/2023 Labeler - PHARMACURE LLC (055983858)