FDA Label for Menthol
View Indications, Usage & Precautions
Menthol Product Label
The following document was submitted to the FDA by the labeler of this product Alexso, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 4%
Purpose
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 older | apply 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, 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
NDC 50488-1040-1
Menthol 4% Cream
120 grams
* Please review the disclaimer below.