MENTHOL

Manufacturer
CHEMCO CORPORATIOM
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:11

Label at a glance#

ProductMENTHOL
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Dosage and administration

Adults and Children over 12 years Apply a small amount to the affected area. Massage in circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic

USE

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS SECTION

For external use only. · Ask a doctor before use if you have redness over affected area

OTC - WHEN USING SECTION

Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken or irritated skin.
If you experience an allergic reaction, discontinue use and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

OTC - STOP USE SECTION

Stop use and ask a doctor if

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

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 over 12 years

Apply a small amount to the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Carbomer, Sodium Hydroxide, Cannabis Sativa Seed Oil, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid.

PAIN RELIEF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEFPAIN RELIEF

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49283-577-03MENTHOL90 mL in 1 BOTTLE, WITH APPLICATORGEL902

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49283-57749283-577-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact identifier
ndc (package): 49283-577-03
ndc (product): 49283-577
ndc11 (package): 49283057703
spl id: 472fb2a3-fb5f-c07b-e063-6394a90a1c7c
spl set id: 472fb99c-dcc2-d9a9-e063-6294a90a794c

Reported adverse events (FAERS/openFDA)#

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