Label: ZYLOTROL MAXIMUM PAIN PATCH- lidocaine 4%, menthol 1% patch

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

Drug Label Information

Updated October 20, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%

    Menthol 1%

  • PURPOSE

    Topical Analgesic

  • WARNINGS

    For external use only not intended for ingestion.

  • DO NOT USE

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

    • Avoid contact with eyes.
  • ASK DOCTOR

    • 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

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

  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

  • 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

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

    polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization; purified water.

  • Questions?

    (310) 320-0100

  • USES

    For the temporary relief of pain.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    ZYLOTROL MAXIMUM PAIN PATCH 
    lidocaine 4%, menthol 1% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-144(NDC:81902-101)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 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
    WATER (UNII: 059QF0KO0R)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    ETHENYL (UNII: PQ2K3G3591)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-144-1515 in 1 BOX08/20/2021
    14 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/30/2021
    Labeler - ASCLEMED USA INC. (059888437)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASCLEMED USA INC. DBA ENOVACHEM059888437relabel(76420-144)
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