FDA Label for Lidocaine And Menthol
View Indications, Usage & Precautions
Lidocaine And 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.
Purpose
Lidocaine 4% ………………………..Topical anesthetic
Menthol 1% …………………………Topical analgesic
Uses
Temporarily relieves pain and itching due to:
- minor cuts
- sunburn
- minor scrapes
- minor burns
- insect bites
- minor skin irritations
Warnings
For external use only.
When Using This Product
- do not use in or near 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 | do not use except under the advice and supervision of a physician |
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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Glucosamine Sulfate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine, Zemea (Corn) Propanediol
Lidocaine 4% and Menthol 1% Gel
NDC 50488-6641-1
120 grams
Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064
Principal Display Panel
NDC 50488-6641-1
Lidocaine 4% + Menthol 1%
120 grams
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