Label: TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT- 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 April 23, 2021

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

  • ACTIVE INGREDIENTS (in each patch)

    Lidocaine 4%
    Menthol 1%

  • INACTIVE INGREDIENTS

    Glycerin, D-Sorbitol Solution, Propylene Glycol, Sodium Polyacrylate, Polyacrylic Acid, Urea, Carboxymethylcellulose Sodium, Gelatin, Kaolin, Titanium Oxide, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Propylparaben, Water

  • PURPOSE

    Topical Anesthetic
    Topical Analgesic

  • WARNINGS

    For external use only
    Safety Warning : Prior to using the product, conduct a skin patch test on your forearm to assess sensitivity and/or allergic reactions
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    Do not use
    ■ More than 1 patch on your body at a time ■ On the cut, irritated, swollen or puncture wounds ■ For more than one week without consulting a doctor
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    Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
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    When using this product
    ■ 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 ■ Make sure to dispose the used patch away from children and pets, as used ones still contain the drug that can cause serious adverse effects on them if they chew or ingest the patch
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    Stop use and ask a doctor if
    ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied
    --------------------------------------------------------------------------------------------------------
    If pregnant or breast-feeding, ask a health professional before use
    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

  • Keep out of reach of children and pets

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

  • Uses

    For temporary relief of minor pain

  • Directions

    Adult and children 12 years of age and over :
    ■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours
    Children under 12 years of age : consult a physician

  • Other Information

    ■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

  • Questions or Comments

    ■ Visit us at : icure.co.kr/en ■ Contact us : icurepharm@icure.co.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73279-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine240 mg
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol60 mg
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Urea (UNII: 8W8T17847W)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Gelatin (UNII: 2G86QN327L)  
    Kaolin (UNII: 24H4NWX5CO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Tartaric Acid (UNII: W4888I119H)  
    Dihydroxyaluminum Aminoacetate (UNII: DO250MG0W6)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73279-0004-25 in 1 CARTON07/01/2020
    1NDC:73279-0004-11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2020
    Labeler - Icure Pharmaceutical Inc, Wanju Factory (695687612)
    Registrant - Icure Pharmaceutical Inc, Wanju Factory (695687612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Icure Pharmaceutical Inc, Wanju Factory695687612manufacture(73279-0004)