Label: COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL- lidocaine, menthol patch

  • NDC Code(s): 70000-0558-1
  • Packager: Cardinal Health, 110 dba LEADER
  • 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 January 11, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Lidocaine 4% Topical Anesthetic

    Menthol 1% Topical Anesthetic

  • PURPOSE

    Topical Anesthetic

  • USES

    Temporary relief of minor pain

  • WARNINGS

    • For External use only. Use only as directed.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    ■ More than one patch on your body at a time

    ■ On cut, irritated or swollen skin

    ■ On puncture wounds

    ■ For more than one week without consulting a doctor

    ■ If you are allergic to any active or inactive ingredients

    ■ If pouch is damaged or opened.

    If pregnant or breast feeding

    • Contact a physician prior to use.

    WHEN USING:

    ■ Use only as directed

    ■ Read and follow all directions and warnings on this carton

    ■ Do not allow contact with the eyes

    ■ Do not use at the same time as other topical analgesics

    ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

    ■ Do not microwave

    ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
    the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

    Stop use and consult a doctor if

    ■ Condition worsens

    ■ Redness is present

    ■ Irritation develops

    ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • DIRECTIONS Adults and children 12 years of age and over:

    Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
    of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
    Children under 12 years of age: consult a physician.

  • INACTIVE INGREDIENTS

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
    propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • STORAGE AND HANDLING

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Lidocaine + Menthol Patch

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

    LidoSpot

  • INGREDIENTS AND APPEARANCE
    COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0558
    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 - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0558-15 in 1 POUCH07/01/2018
    19 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2018
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(70000-0558)
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