Methyl Salicylate

Manufacturer
Florrax Pharmaceutical Corp.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:29

Label at a glance#

ProductMethyl Salicylate
Active ingredientMETHYL SALICYLATE
Label structure12 sections

Indications and 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.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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:

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

CONSULT PHYSICIAN FOR CHILDREN UNDER 18.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10%

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053397methyl salicylate 10 % Medicated PatchPSN1
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCD1
1053397methyl salicylate 10 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84460-103-01Methyl Salicylate2 in 1 BOXPATCH21
84460-103-01Methyl Salicylate5 in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84460-103METHYL SALICYLATE (METHYL SALICYLATE 10%) PATCH [FLORRAX PHARMACEUTICAL CORP.]1Current NDC, 2 package rows20250221_2dd5226c-e7e0-cca0-e063-6394a90a32a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84460-103-01EA - Each84460-10311186450-2d00-453f-9bd4-222ae6c6fb7912025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84460-10384460-103-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATE 10%Florrax Pharmaceutical Corp.2dd5226c-e7e0-cca0-e063-6394a90a32a52025-02-10WarningsExact identifier
ndc (package): 84460-103-01
ndc (product): 84460-103
ndc11 (package): 84460010301
spl id: 2dd5226c-e7e1-cca0-e063-6394a90a32a5
spl set id: 2dd5226c-e7e0-cca0-e063-6394a90a32a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.