Label: METHYL SALICYLATE- methyl salicylate 10% patch

  • NDC Code(s): 84460-103-01
  • Packager: Florrax Pharmaceutical Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 10, 2025

If you are a consumer or patient please visit this version.

  • 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 affected area
    • Open pouch and remove one patch
    • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form 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 of pieces of cut patches where children and pets cannot get to them.

    Children under 18 years: Ask a physician

  • Purpose

    External 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 healthcare professional. Read all warnings and directions before us. 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

    Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

  • When using this product

    • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensatoin generally disappears after several days.
    • Avoid contact with the eyes, lips, nose and mucous membranes
    • You may experiences 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 no apply heat to the treated area immediately before or after use
  • Stop use and ask a physician 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
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    CONSULT PHYSICIAN FOR CHILDREN UNDER 18.

  • Active Ingredient

    Methyl Salicylate 10%

  • Other Information

    May be applied under occlusive dressing.

    Store at 20-25°C (68-77°F); excursions permitted to 15-30°C(59-86°F). See USP Controlled Room Temparature

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 
    methyl salicylate 10% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84460-103
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84460-103-012 in 1 BOX02/10/2025
    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 Drug505G(a)(3)02/10/2025
    Labeler - Florrax Pharmaceutical Corp. (119257612)