1. Home
  2. Labeler Index
  3. Violacare, Inc.
  4. 85231-101
  5. Label Information: Methyl Salicylate 10%

FDA Label for Methyl Salicylate 10%

View Indications, Usage & Precautions

Table of Contents

    1. ​
    2. ACTIVE INGREDIENTS:
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP AND ASK A DOCTOR IF
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Methyl Salicylate 10% Product Label

The following document was submitted to the FDA by the labeler of this product Violacare, 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.

​



Drug Facts


Purpose



External analgesic


Uses



Temporarily relieves aches & pains of muscles & joints associated with:

  • Stains
  • 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 as NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using 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 been open for 14 or more days
  • right before or after heat surgery

Ask A Doctor Before Use If



  • 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



  • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the water.
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop 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.

Directions



Adults and Children 10 years of age and older:

  • only use one patch at a time
  • clean and dry affected area
  • remove patch from backing film and apply to skin (see illustration)
  • apply 1 patch to the affective area of intact skin up to 24 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

Other Information



  • Store at 20-25°C (66-77°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

Inactive Ingredients



Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide 


Questions Or Comments?



Call 877-227-3137


* Please review the disclaimer below.