MENTHOL ROLL ON

Manufacturer
Medhome Pharma Inc | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:24

Label at a glance#

ProductMENTHOL ROLL ON
Active ingredientMENTHOL
Label structure15 sections

Indications and uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

Dosage and administration

Adults and children 12 years of age and older: • Rub a thin film over affected areas not more than 4 times daily; • Message not necessary Children under 12 years of age: Consult physician. Wash hands after use with cool water.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4% ...... Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

USE IN SPECIFIC POPULATIONS SECTION

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on wounds or damaged skin

• with a heating pad or device

• with other ointments, creams, sprays, or liniments

• if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

• use only as directed

• avoid contact with the eyes, mucous membranes, or rashes

• do not bandage tightly

Stop use ... if

OTC - STOP USE SECTION

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

... ask a doctor if

OTC - ASK DOCTOR SECTION

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Directions

INDICATIONS & USAGE SECTION

Adults and children 12 years of age and older:

• Rub a thin film over affected areas not more than 4 times daily;

• Message not necessary

Children under 12 years of age: Consult physician.

Wash hands after use with cool water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water

Questions or Comments:

OTC - QUESTIONS SECTION

cs@medhomegroup,com

Dosage

DOSAGE & ADMINISTRATION SECTION

74 mL in 1 BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84007-333-01MENTHOL ROLL ON74 mL in 1 BOTTLELIQUID, EXTENDED RELEASE741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84007-333MENTHOL ROLL ON (PAIN RELIEF GEL) LIQUID, EXTENDED RELEASE [MEDHOME PHARMA INC]11 package rows20240718_1d68e805-b8da-aa0d-e063-6394a90a2e3c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84007-33384007-333-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
1d68e805-b8db-aa0d-e063-6394a90a2e3c1d68e805-b8da-aa0d-e063-6394a90a2e3c2024-07-16WarningsExact identifier
spl id: 1d68e805-b8db-aa0d-e063-6394a90a2e3c
spl set id: 1d68e805-b8da-aa0d-e063-6394a90a2e3c

Reported adverse events (FAERS/openFDA)#

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