OTC Medication Information: Lidocaine 4 Percent and Menthol 1 Percent Roll-On

LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON- lidocaine hydrochloride and menthol liquid
Alexso, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

LIDOCAINE AND MENTHOL — L idocaine 4% and Menthol 1 % Roll-On
Alexso, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Lidocaine 4% and Menthol 1 % Roll-On

​Drug Facts

Active ingredient

Lidocaine 4%
Menthol 1%

Purpose

Topical anesthetic
Topical anesthetic

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

Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, Water

PRINCIPAL DISPLAY PANEL

Lidocaine 4% and Menthol 1 % Roll-On

NDC 50488-6541-1

50 mL

Manufactured for:
Alexso, Inc. Los Angeles, CA 90064

Lidocaine 4% and Menthol 1% Roll-On
NDC 50488-6541-1
50 mL

Manufactured for: 
Alexso, Inc. 
Los Angeles, CA 90064
(click image for full-size original)
LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON lidocaine and menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-6541
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 50 mL
MENTHOL (MENTHOL) MENTHOL 0.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
BORNEOL
ARNICA MONTANA FLOWER
POLYETHYLENE GLYCOL, UNSPECIFIED
FRANKINCENSE OIL
BOSWELLIA SACRA WHOLE
DIMETHYL SULFONE
CHONDROITIN SULFATE (BOVINE)
GLUCOSAMINE SULFATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-6541-1 50 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 02/17/2021
Labeler — Alexso, Inc (963338061)

Revised: 02/2021 Alexso, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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