Label: METHYL SALICYLATE patch
- NDC Code(s): 79643-003-01
- Packager: PHARMACURE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 13, 2023
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- Active Ingredient Purpose
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.
- KEEP OUT OF REACH OF CHILDREN
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 patch
Product 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 not final part348 02/17/2023 Labeler - PHARMACURE, INC. (055983858)