Label: RE-LIEVED LIDOCAINE PATCH- lidocaine patch 4% 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 January 20, 2021

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  • Active Ingredients

    Lidocaine 4%

    Menthol 1%

  • Purpose

    Topical Analgesic

  • Use

    For the temporary relief of pain.

  • Warnings

    For external use only. The adhesoin properties of this patch may cause an extended period of redness. Please visit www.re-lieved.com for more information.

  • Do not use

    If you are allergic to Lidocaine. On open wounds or on damaged, broken or irritated skin. Remove immidiately if you sense a burning sensation after application.

  • When using this product

    • Do not use other topical products
    • Do not allow contact with eyes or mucous membranes
    • Keep away from excessive heat. Do not apply heating pad to area of use
    • Apply only to clean, dry and untreated skin
    • Use only as directed. Read and follow all directions and warnings on this label
  • Ask your doctor or pharmacist before use if you are

    using blood thinning medication, steroids, or non-steroidal anti-inflammatory druns (NSAIDs), or if you have sensitive skin.

  • Stop use or ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days
  • If pregnant or breast feeding

    ask a physician before use.

  • Keep out of reach of children

    If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

  • Directions adults/children 12 years or older

    • Clean and dry affected area
    • Peel patch off plastic liner and place on affected area for no more than 12 hours
    • Wash hands after applying patch.
    • Under age 12, consult a physician before use
    • For easier removal of the patc, apply rubbing alcohol or baby oil to adhesive edge while gently peeling
  • Other information

    • store at room termperature
    • Do not exceed 100 o Fahrenheit, 38 o Celsius
  • Inactive Ingredients

    Acrylic adhesive, Polyethylene fabric

  • Re-Lieved Lidocaine-Menthol

    Re-Lieved Lidocaine plus Menthol

  • INGREDIENTS AND APPEARANCE
    RE-LIEVED LIDOCAINE PATCH 
    lidocaine patch 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71662-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-1 mg  in 100 mg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71662-001-065 mg in 1 POUCH; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2021
    Labeler - Transfer Technology (037968132)
    Registrant - Transfer Technology (037968132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Transfer Technoloy037968132manufacture(71662-001)
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