Methyl Salicylate 10% Patch

Methyl Salicylate 10% Patch by

Drug Labeling and Warnings

Methyl Salicylate 10% Patch by is a Otc medication manufactured, distributed, or labeled by FORREAL PHARMACEUTICALS LLC . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

METHYL SALICYLATE 10% PATCH- methyl salicylate 10% patch 
FORREAL PHARMACEUTICALS LLC

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Methyl Salicylate 10% Patch

Drug Facts

Active ingredients:

Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)

Purpose

Topical analgesic

Uses

Temporarily relieves 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 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 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 right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

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.
  • 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 (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

Inactive ingredients

Polysorbate 80, Glycerine, Sodium Cellulose Glycolate, Sodium Polyacrylate, Vitamin E, EDTA Disodium Salt, Kaolin, Water, Methylparaben

Questions or comments?

877.367.3250

PRINCIPAL DISPLAY PANEL

Forreal Pharmaceuticals
YOUR SOLUTION TO BETTER HEALTHCARE.

NDC: 81877-722-10

METHYL SALICYLATE 10%
Topical Analgesic (NSAID)

TOPICAL PAIN PATCH

For Temporary Pain Relief

Qty: 10 Flexible Patches
(5 Per Resealable Pouch) x2
8cm x 12cm

PRINCIPAL DISPLAY PANEL Methyl Salicylate 10% Patch

METHYL SALICYLATE 10% PATCH 
methyl salicylate 10% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81877-722
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-10 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KAOLIN (UNII: 24H4NWX5CO)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81877-722-1010 in 1 BOX; Type 0: Not a Combination Product04/15/202406/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart34804/15/202406/07/2024
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

Revised: 6/2024