FDA.reportPublic FDA data

Methyl Salicylate 10%

Manufacturer
PureTek Corporation
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:02

Label at a glance#

ProductMethyl Salicylate 10% Pain Relieving
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician

Storage and handling

■ store between 20° to 25° C (68°- 77° F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints.

Warnings

WARNINGS SECTION

■ For External Use Only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ Keep this and all other drugs out of the reach of children.

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or broken skin ■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ pain persists for more than 7 days, redness is present or in conditions affecting children under 12 years of age. ■ excessive irritation of the skin develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

■ If pregnant or breastfeeding ■ ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician

STORAGE AND HANDLING SECTION

■ store between 20° to 25° C (68°- 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer. Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol , Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Fragrance.

Methyl Salicylate 10%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free: 1-877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311635methyl salicylate 10 % Topical CreamPSN1
311635methyl salicylate 100 MG/ML Topical CreamSCD1
311635methyl salicylate 10 % Topical CreamSY1

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
59088-243-06Methyl Salicylate 10%Pain Relieving60 g in 1 JARCREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-243-06GM - Gram59088-24341ca8066-7c90-4da7-abfe-94b9843f8d2e12025-08-11

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-24359088-243-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENHADEN OIL1D8HWC57D0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
ALOE VERA LEAFZY81Z83H0XIACT
BORAGE SEED OILF8XAG1755SIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
EUCALYPTUS OIL2R04ONI662IACT
FRUCTOSE6YSS42VSEVIACT
METHYL SALICYLATELAV5U5022YACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GRAPE SEED OIL930MLC8XGGIACT
SODIUM HYDROXIDE55X04QC32IIACT

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 Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
ndc (package): 59088-243-06
ndc (product): 59088-243
ndc11 (package): 59088024306
spl id: 376493eb-5143-db6d-e063-6294a90a1e73
spl set id: 376493eb-5142-db6d-e063-6294a90a1e73

Reported adverse events (FAERS/openFDA)#

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