FDA.reportPublic FDA data

Menthol Cream

Manufacturer
Alexso, Inc
Effective date
2019-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:18

Label at a glance#

ProductMenthol
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Storage and handling

May be applied under occlusive dressing. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Menthol 4% Cream
Alexso, Inc

----------

Menthol 4% Cream 

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • Do not apply to wounds or damaged skin
  • Do not bandage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

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 2 years and olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Menthol 4% Cream

NDC: 50488-1040-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-1040-1
Menthol 4% Cream
120 grams

PRINCIPAL DISPLAY PANEL NDC 50488-1040-1 Menthol 4% Cream 120 gramsPRINCIPAL DISPLAY PANEL NDC 50488-1040-1 Menthol 4% Cream 120 grams

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148430menthol 4 % Topical CreamPSN2
1148430menthol 40 MG/ML Topical CreamSCD2
1148430menthol 4 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50488-1040-12024-01-30C16284748780-11030e365-6bb1-111a-e063-dadaa90a10e2Menthol Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1040-1Menthol120 g in 1 BOTTLECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1040MENTHOL CREAM [ALEXSO, INC]2Legacy NDC, 1 package rows20190420_ebfd4e87-3dd4-4db0-a26b-3a11a9811886.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1040-1GM - Gram50488-104056f4cfe5-0d24-49ad-837d-b9cd2782121512019-05-02

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-104050488-1040-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
LAURETH-7Z95S6G8201IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT

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
d452ca4e-4a2f-410d-9b15-4c87d3904d91ebfd4e87-3dd4-4db0-a26b-3a11a98118862019-04-24WarningsExact identifier
spl id: d452ca4e-4a2f-410d-9b15-4c87d3904d91
spl set id: ebfd4e87-3dd4-4db0-a26b-3a11a9811886

Reported adverse events (FAERS/openFDA)#

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