Menthol

Manufacturer
Jag Alliance, LLC | Chemco Corporation
Effective date
2020-12-11
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
legacy-cache
Hydrated at
2026-08-01 23:01:17

Label at a glance#

ProductMenthol
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children two-years of age or older:  Apply to affected area not more than three to four times daily.  Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol  10%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult a physician.

IF PREGNANT OR BREAST – FEEDING:

  • Ask a health professional before use.

KEEP OUT OF REACH OF CHILDEN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.
  • Emergency Number: 1-800-222-1222

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age or older:

  •  Apply to affected area not more than three to four times daily.
  •  Children under two-years of age: consult a physician.

Additional Information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Caprylic/Capric Triglyceride, Alcohol Denat., Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Helianthus Annuus Seed Oil, Butyrospermum Parkii Butter, Cannabis Sativa Seed Oil, Glycereth-26, Persea Gratissima Oil, Stearyl Alcohol, Sodium Polyacrylate, Aloe Barbadensis Leaf Extract, Glycerin, Boswellia Serrata Extract, Melaleuca Alternifolia Leaf Oil, Mentha Arvensis Herb Oil, Arnica Montana Flower Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RUBPAIN RUB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73143-010-032025-01-14C16284748780-1d6a99b3a-00f5-a426-e053-dadaa90af4c273143-010-03
73143-010-032022-01-28C16284748780-1d6a99b3a-00f5-a426-e053-dadaa90af4c273143-010-03

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
73143-01073143-010-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
2bae5641-9afa-96cd-e063-6394a90ae3488de2037b-c6ee-1ba9-e053-2a95a90ab1ef2025-01-14WarningsExact identifier
spl set id: 8de2037b-c6ee-1ba9-e053-2a95a90ab1ef

Reported adverse events (FAERS/openFDA)#

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