Label: ZYLOTROL- lidocaine hcl 4%, menthol 1% gel

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

Drug Label Information

Updated October 16, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain.

  • WARNINGS

    Warnings

    For external use only not intended for ingestion.

  • DO NOT USE

    Do not use

    • in large quantities, particularly over raw surfaces, or blistered areas.
  • WHEN USING

    When using this product

    • Avoid contact with the eyes.
  • ASK DOCTOR

    Stop use and ask a doctor if

    • condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help, or contact a Poison Control Central right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
    • Children under 2 years of age: consult a doctor.
  • OTHER SAFETY INFORMATION

    Other information

    • Store at 20-25 oC (68-77 oF) and protect from moisture.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.

  • QUESTIONS

    Questions?

    (310) 320-0100

  • SPL UNCLASSIFIED SECTION

    Relabeled by:
    Enovachem PHARMACEUTICALS
    Torrance, CA 90501

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ZYLOTROL 
    lidocaine hcl 4%, menthol 1% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-145(NDC:81902-201)
    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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-145-041 in 1 BOX06/12/2022
    1118.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/12/2022
    Labeler - Asclemed USA, Inc. (059888437)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASCLEMED USA INC. DBA ENOVACHEM059888437relabel(76420-145)
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