Label: LIDONEXE- lidocaine, menthol patch

  • 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 November 18, 2014

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  • Lidonexe Patch


  • Active Ingredients:

    Lidocaine HCL 4.00%

    Menthol 1.00%


  • Purpose

    Topical Analgesic

    External Analgesic

  • Uses:

    For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.

  • Warnings

    • For external use only
    • Avoid contact with eyes
    • Do not apply to open wounds or damaged skin.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.


    • Do not bandage tightly
    • If pregnant or breast feeding, contact physician prior to use.
    • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Directions

    • Clean and dry affected area.
    • Remove patch from backing and apply to affected area.
    • Use only one patch at a time, and maximum of four patches/day.
    • Leave patch on affected area for up to 8-hours.
    • Do not use patches for longer than five consecutive days.
    • Children under 12 should consult physician prior to use.
  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.

  • Store below 25 degrees. Avoid direct sunlight.


  • Lidonexe 25 patches (69329 -002-25)

    lindonexe_label_small.jpg

  • INGREDIENTS AND APPEARANCE
    LIDONEXE 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69329-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69329-002-055 in 1 BOX
    110 g in 1 PATCH
    2NDC:69329-002-2525 in 1 BOX
    210 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/10/2014
    Labeler - Patchwerx Labs, Inc. (079584480)
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