LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON- lidocaine 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 Roll-On

LIDOCAINE AND MENTHOL - Lidocaine 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:

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

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

LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON 
lidocaine and menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6541
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 50 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BORNEOL (UNII: M89NIB437X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-6541-150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product02/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/17/2021
Labeler - Alexso, Inc (963338061)

Revised: 2/2021
Document Id: e2dc4651-36ef-4bc9-b427-718e53292dbc
Set id: 511ee92e-f69c-4d21-aadd-84a06aca00c2
Version: 2
Effective Time: 20210223
 
Alexso, Inc