Label: LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON- lidocaine and menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 23, 2021

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  • SPL UNCLASSIFIED SECTION

    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.

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    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

  • INGREDIENTS AND APPEARANCE
    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)
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