Label: LIDOCAINE 4% PLUS MENTHOL 1%- 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 September 3, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    lidocaine, menthol

  • INACTIVE INGREDIENT

    Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

  • PURPOSE

    Temporary relief of minor pain

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Use only as directed. Read and follow all directions and warnings on this label.
    Do not allow contact with the eyes and mucous membranes
    Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    Do not use at the same time as other topical analgesics
    Dispose of used patch in manner that always keeps product away from children and pets
    Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

  • WARNINGS

    - Warnings
    For external use only.
    Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.

    - Do not Use
    More than 1 patch on your body at a time or on cut, irritated or swollen skin
    On puncture wounds
    For more than one week without consulting a doctor

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% PLUS MENTHOL 1% 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73279-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73279-0001-25 in 1 POUCH08/31/2019
    1NDC:73279-0001-16 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2019
    Labeler - Icure Pharmaceutical Inc, Wanju Factory (695687612)
    Registrant - Icure Pharmaceutical Inc, Wanju Factory (695687612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Icure Pharmaceutical Inc, Wanju Factory695687612manufacture(73279-0001) , label(73279-0001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!