Menthol 10 Percent Plus Camphor 4 Percent
FDA Label NDC 50488-0410

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Menthol 10 Percent Plus Camphor 4 Percent (NDC 50488-0410). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

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

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.

Warnings

​For external use only.

When Using This Product

  • 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

  • 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 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

  • 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

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

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

Principal Display Panelndc 50488-0410-1menthol 10% + Camphor 4% Cream120 Grams (Menthol And Camphor Cream 01)

Principal Display Panelndc 50488-0410-1menthol 10% + Camphor 4% Cream120 Grams (Menthol And Camphor Cream 01)

* Please review the disclaimer below.