Label: LIDOCAINE AND MENTHOL- lidocaine, menthol gel

  • 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 17, 2021

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  • SPL UNCLASSIFIED SECTION

    LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Gel
    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% Gel

    ​Drug Facts

  • Active ingredient

  • 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

    PRINCIPAL DISPLAY PANEL NDC 50488-6641-1 Lidocaine 4% + Menthol 1% 120 grams

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE AND MENTHOL 
    lidocaine, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6641
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.8 g  in 120 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-6641-1120 g in 1 TUBE; 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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