FDA.reportPublic FDA data

MENTHOL AND METHYL SALICYLATE

Manufacturer
FEI FAH MEDICAL MANUFACTURING PTE LTD
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:10

Label at a glance#

ProductMENTHOL AND METHYL SALICYLATE
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure13 sections

Storage and handling

Other information keep container tightly closed store at 15° to 30°C (59° to 86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Menthol 16%
Methyl salicylate 32%

OTC - PURPOSE SECTION

Purpose
External analgesic
External analgesic

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of minor aches and pains of muscles and joints due to
simple backache
arthritis
strains
bruises
sprains

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use
on wounds
on irritated or damaged skin
on the face
otherwise than as directed

OTC - WHEN USING SECTION

When using this product
avoid contact with the eyes or mucous membranes
do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
when using for pain of arthritis
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily.
Children under 3 years of age: Do not use, consult your doctor.

STORAGE AND HANDLING SECTION

Other information
keep container tightly closed
store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients
Petrolatum

OTC - QUESTIONS SECTION

Questions or comments? (888) 221-3496 M-F 9am to 5pm
you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELECTRIC MEDICATED BALM
External Analgesic
NDC 63299-001-01
NET 2.45 oz (70g)
Box1.jpgBox1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2002730menthol 16 % / methyl salicylate 32 % Topical OintmentPSN3
2002730menthol 0.16 MG/MG / methyl salicylate 0.32 MG/MG Topical OintmentSCD3
2002730menthol 16 % / methyl salicylate 32 % Topical OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63299-001-01MENTHOL AND METHYL SALICYLATE1 in 1 BOXOINTMENT13
63299-001-01MENTHOL AND METHYL SALICYLATE70 g in 1 JAROINTMENT703
63299-001-02MENTHOL AND METHYL SALICYLATE10 g in 1 JAROINTMENT103
63299-001-02MENTHOL AND METHYL SALICYLATE1 in 1 BOXOINTMENT13

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63299-00163299-001-01, 63299-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-19full-release2026-06-01 00:38:05

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
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
ndc (package): 63299-001-01
ndc (package): 63299-001-02
ndc (product): 63299-001
ndc11 (package): 63299000102
ndc11 (package): 63299000101
spl id: 4344ef98-ce28-2cec-e063-6294a90a1c74
spl set id: 91e6d3b9-25bb-4015-9d96-bd27f93e5ada

Reported adverse events (FAERS/openFDA)#

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