Label: LENZAGEL- lidocaine hydrochloride, 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 October 2, 2013

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  • LenzaGel


  • 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

    • Apply directly to effected area. Do not use more than four times per day.
  • 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.

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    IMAGE LABEL

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

  • INGREDIENTS AND APPEARANCE
    LENZAGEL 
    lidocaine hydrochloride, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53217-026(NDC:45861-016)
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53217-026-01120 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/01/2013
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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