FDA.reportPublic FDA data

Mencylate

Manufacturer
PureTek Corporation
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:40

Label at a glance#

ProductMencylate Pain Relieving
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Storage and handling

• Store at controlled room temperature 20°-25°C (68°-77°F).

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION


Menthol 2.0%
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 associated with • simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

• apply on wounds or damaged skin • bandage tightly

When using this product

OTC - WHEN USING SECTION

• avoid contact with the eyes or mucous membranes • do not use other than as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• Store at controlled room temperature 20°-25°C (68°-77°F).

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Mencylate TM

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
311503menthol 2 % / methyl salicylate 10 % Topical CreamPSN3
311503menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD3
311503menthol 2 % / methyl salicylate 10 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-215-05MencylatePain Relieving59 mL in 1 JARCREAM593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-215MENCYLATE PAIN RELIEVING (MENTHOL, METHYL SALICYLATE) CREAM [PURETEK CORPORATION]3Current NDC, 1 package rows20241004_f824de86-9492-2e6b-e053-6294a90a6f2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-215-05ML - Milliliter59088-215cabea204-fd22-4a34-ac6a-0b1e4daad14b12023-05-05

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-21559088-215-05

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
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BORAGE SEED OILF8XAG1755SIACT
CARBOMER 934Z135WT9208IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
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
MENTHOLL7T10EIP3AACTIB
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
Mencylate Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationf824de86-9492-2e6b-e053-6294a90a6f2a2024-10-01WarningsExact identifier
ndc (package): 59088-215-05
ndc (product): 59088-215
ndc11 (package): 59088021505
spl id: 23734cfb-47fb-fb71-e063-6394a90a85de
spl set id: f824de86-9492-2e6b-e053-6294a90a6f2a

Reported adverse events (FAERS/openFDA)#

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