METHYL SALICYLATE- methyl salicylate patch 
Alexso, Inc

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.

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Methyl Salicylate Patch

Drug Facts

Active ingredient

Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

​For external use only. Use only as directed or as directed by a health care professional.

Read all warnings and directions before use.

Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Do not use:

• On wounds, cuts, damaged or infected skin

• On eyes, mouth, genitals, or any other mucous membranes

Keep out of reach of children.

Consult physician for children under 18.

When using this product

  • Avoid contact with the eyes
  • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • Do not tightly wrap or bandage the treated area
  • Do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Directions

Adults and children 18 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

- Clean and dry the affected area.

- Open pouch and remove one patch.

- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.

- Wash hands with soap and water after handling the patches.

- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 18 years: Ask a physician

Other information

Inactive ingredients

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

Methyl Salicylate 10% Patch 

NDC: 50488-2010-1

10 Patches

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

Methyl Salicylate 10% Patch
Topical Analgesic
NDC 50488-2010-1
10 Patches

PRINCIPAL DISPLAY PANEL
Methyl Salicylate 10% Patch
Topical Analgesic
NDC 50488-2010-1
10 Patches

METHYL SALICYLATE 
methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-2010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KAOLIN (UNII: 24H4NWX5CO)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-2010-12 in 1 BOX02/11/2021
15 in 1 POUCH
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/11/2021
Labeler - Alexso, Inc (963338061)

Revised: 2/2021
Document Id: b40f677d-3b13-4e6d-8800-b7ba6443c67a
Set id: bac67f94-8627-47ff-a736-37feab77330a
Version: 1
Effective Time: 20210211
 
Alexso, Inc