Mentholatum

Manufacturer
Lydia Co., Ltd.
Effective date
2023-07-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:55

Label at a glance#

ProductMentholatum
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate, DL-Menthol

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily ■ children under 2 years of age: consult a doctor

WARNINGS SECTION

Warnings For external use only. Flammable ■ Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly. Stop use and ask a doctor if ■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days When using this product ■ Use only as direct ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly If pregnant or breast-feeding, ask a health professional before use Keep out of reach of childre

INACTIVE INGREDIENT SECTION

mineral oil, lantrol, Sorbitan Monostearate, etc

DOSAGE & ADMINISTRATION SECTION

topocal use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282812menthol 6 % / methyl salicylate 20 % Topical LotionPSN3
282812menthol 60 MG/ML / methyl salicylate 200 MG/ML Topical LotionSCD3
282812menthol 6 % / methyl salicylate 20 % Topical LotionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0031-1Mentholatum75 g in 1 BOTTLELOTION753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0031MENTHOLATUM (METHYL SALICYLATE, DL-MENTHOL) LOTION [LYDIA CO., LTD.]3Current NDC, Legacy NDC, 1 package rows20230819_e9db590f-b19a-3fe8-e053-2995a90a4e74.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-003172988-0031-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
MentholatumMETHYL SALICYLATE, DL-MENTHOLLydia Co., Ltd.e9db590f-b19a-3fe8-e053-2995a90a4e742023-07-06WarningsExact identifier
ndc (package): 72988-0031-1
ndc (product): 72988-0031
ndc11 (package): 72988003101
spl id: ffcab802-a76f-e425-e053-6294a90acf76
spl set id: e9db590f-b19a-3fe8-e053-2995a90a4e74

Reported adverse events (FAERS/openFDA)#

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