FDA.reportPublic FDA data

Medicated Oil

Manufacturer
Luoyang Muchun Pharmaceutical Co, Ltd
Effective date
2018-07-05
Label type
HUMAN OTC DRUG LABEL
Version
32458
Source
full-release
Hydrated at
2026-05-31 22:58:47

Label at a glance#

ProductMedicated Oil
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and older: Apply to the affected area 3 to 4 times daily. Children under 12 years of age:  Do not use, consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol     8%
Methyl Salicylate     26%

Purpose

OTC - PURPOSE SECTION

Menthol      Topical Analgesic
Methyl Salicylate      Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply to the affected area 3 to 4 times daily. Children under 12 years of age:  Do not use, consult a doctor.

Warning

WARNINGS SECTION

For External Use Only.

When Using This Product

OTC - WHEN USING SECTION

Use only as directed.
Do not get into eyes or mucous membranes.
Do not apply to wound or damaged skin.
Do not bandage tightly.
Pregnant or lactating women consult a doctor before using.

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.
People with allergic conditution consult a doctor before using.

Other Information

OTHER SAFETY INFORMATION

Keep bottle tightly closed and store at temperature below 25°C (77°F).

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Manufactured by

SPL UNCLASSIFIED SECTION

Luoyang Muchun Pharmaceutical Co, Ltd.

Distributed by Magic Wand (Beijing) Trading Co, Ltd

1501-1502, 15th F, Building 3, No. 3 Zhonghe Road, Fengtai District, Beijing 100070

Made in China

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CLOVE OIL, EUCALYPTUS GLOBULUS LEAF, CINNAMON OIL, PARAFFIN, ROSE OIL, PEPPERMINT OIL

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2048953menthol 8 % / methyl salicylate 26 % Topical OilPSN32458
2048953menthol 80 MG/ML / methyl salicylate 260 MG/ML Topical OilSCD32458
2048953menthol 8 % / methyl salicylate 26 % Topical OilSY32458

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72323-001-302023-01-30C16284748780-1f386c64a-21b8-0266-e053-dadaa90a7c1aLuoyang Muchun Pharmaceutical Co, Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72323-001-10Medicated Oil10 mL in 1 BOTTLE, GLASSOIL1032458
72323-001-30Medicated Oil1 in 1 BOXOIL132458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72323-001MEDICATED OIL (MENTHOL, METHYL SALICYLATE) OIL [LUOYANG MUCHUN PHARMACEUTICAL CO, LTD]32458Legacy NDC, 2 package rows20190314_979a50b9-ea76-4ce2-bcbd-6252349ae1ec.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72323-00172323-001-10, 72323-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CLOVE OIL578389D6D0IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
CINNAMON OILE5GY4I6YCZIACT
PARAFFINI9O0E3H2ZEIACT
ROSE OILWUB68Y35M7IACT
PEPPERMINT OILAV092KU4JHIACT

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
8a1b1396-43fa-4779-b1c6-6a3c265f96f1979a50b9-ea76-4ce2-bcbd-6252349ae1ec2018-07-05WarningsExact identifier
spl id: 8a1b1396-43fa-4779-b1c6-6a3c265f96f1
spl set id: 979a50b9-ea76-4ce2-bcbd-6252349ae1ec

Reported adverse events (FAERS/openFDA)#

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