Label: LIDOZEN- lidocaine hydrochloride, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Lidocaine HCL 4.00%

    Menthol 1.00%

    Topical Anesthetic

    External Analgesic

  • USES:

    For temporary relief of pain

  • WARNINGS:

    • For external use only.
    • Avoid contact with eyes.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
    • Do not use in large quantities, particularly over raw surfaces or blistered areas.
    • ​ ask a health professional before use. ​If pregnant or breast-feeding,

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DIRECTIONS (Adults and Children Over 12 Years):

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

  • INACTIVE 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, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LIDOZEN 
    lidocaine hydrochloride, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
    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)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71574-300-721 in 1 BOX07/22/2017
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/22/2017
    Labeler - Village Pharma, LLC (080749749)
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