Menthol and Camphor Cream

Manufacturer
Alexso, Inc
Effective date
2022-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:19

Label at a glance#

ProductMenthol 10 percent plus Camphor 4 percent
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
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.

Dosage and administration

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

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 10% and Camphor 4% Cream
Alexso, Inc

----------

Menthol 10% and Camphor 4% Cream 

​Drug Facts

Purpose

OTC - PURPOSE SECTION

Menthol 10% ……………………………………..………………….…Topical analgesic
Camphor 4% ……………………………………………………………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 older

apply 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, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, 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 10% and Camphor 4% Cream

NDC: 50488-0410-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-0410-1
Menthol 10% + 
Camphor 4% Cream
120 grams

PRINCIPAL DISPLAY PANEL NDC 50488-0410-1 Menthol 10% + Camphor 4% Cream 120 grams
PRINCIPAL DISPLAY PANEL NDC 50488-0410-1 Menthol 10% + Camphor 4% Cream 120 grams

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2199390camphor 4 % / menthol 10 % Topical CreamPSN2
2199390camphor 40 MG/ML / menthol 100 MG/ML Topical CreamSCD2
2199390camphor 4 % / menthol 10 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50488-0410-12024-01-30C16284748780-11030e365-3588-111a-e063-dadaa90a10e2Menthol and Camphor Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-0410-1Menthol 10 percent plus Camphor 4 percent120 g in 1 BOTTLECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-0410MENTHOL 10 PERCENT PLUS CAMPHOR 4 PERCENT (MENTHOL AND CAMPHOR) CREAM [ALEXSO, INC]2Legacy NDC, 1 package rows20221102_fbab708f-cec9-417a-aa12-905aa9f460cc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-0410-1GM - Gram50488-0410baa25107-5f20-4318-91a3-b60855dd941c12019-10-07

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-041050488-0410-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
97897a7d-04fb-46e0-822f-3c87912f5cb3fbab708f-cec9-417a-aa12-905aa9f460cc2022-10-27WarningsExact identifier
spl id: 97897a7d-04fb-46e0-822f-3c87912f5cb3
spl set id: fbab708f-cec9-417a-aa12-905aa9f460cc

Reported adverse events (FAERS/openFDA)#

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