Methylten Cream

Manufacturer
Puretek Corporation
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:39

Label at a glance#

ProductMethylten
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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10%

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 doctor if

SPL UNCLASSIFIED 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. ■ 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

Other information

OTHER SAFETY INFORMATION

■ 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.

MethyltenTM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by:
PureTek Corporation

Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

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
59088-013-06Methylten60 g in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-013METHYLTEN (METHYL SALICYLATE 10%) CREAM [PURETEK CORPORATION]1Current NDC, 1 package rows20250116_28f4093f-803f-0e70-e063-6294a90a98a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-013-06GM - Gram59088-01348cd8574-4923-47e2-8e45-7b0d73fc298812025-02-10

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
59088-01359088-013-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
ndc (package): 59088-013-06
ndc (product): 59088-013
ndc11 (package): 59088001306
spl id: 28f4093f-8040-0e70-e063-6294a90a98a4
spl set id: 28f4093f-803f-0e70-e063-6294a90a98a4

Reported adverse events (FAERS/openFDA)#

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