Label: HOT AND COLD LIDOCAINE WITH MENTHOL PATCH PAIN RELIEF- lidocaine and 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 June 22, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Lidocaine 4 %Topical analgesic
    Menthol 1%Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

  • Warnings

    For external use only.

    Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

    When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not apply to open wounds or sensitive skin
    • do not bandage tightly or use a heating pad

    Stop use and ask a doctor if

    • excessive redness or irritation is present
    • condition worsens
    • pain persists for more than 7 days
    • symptoms clear up and occur again within a few days

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

    Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.

  • Directions

    • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
    • children: consult your physician
    • remove protective film, gently apply to affected area.
  • Inactive Ingredients

    colloidal silicon dioxide, Kaolin, Polyacrylic acid, Sodium Polyacrylate, Polysorbate, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

    Menthol and lidocaine patch bulk label

  • INGREDIENTS AND APPEARANCE
    HOT AND COLD LIDOCAINE WITH MENTHOL PATCH  PAIN RELIEF
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71318-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71318-001-251125 in 1 CASE06/22/2017
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/03/2017
    Labeler - DR SABHARWAL'S WOUND CARE (862184668)
    Registrant - Velocity Pharma LLC (962198409)
    Establishment
    NameAddressID/FEIBusiness Operations
    DR SABHARWAL'S WOUND CARE862184668manufacture(71318-001)
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