Label: LIDOPATCH 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 March 12, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Lidocaine 3.99%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

    Glycerol, Water, Acrylamide/acrylate co-polymer, (Poly) vinyl pyrrolidone, Germaben II

  • Questions?

    Email info@lidopatch.com

  • SPL UNCLASSIFIED SECTION

    MFG by JAR Laboratories, Elmhurst, IL 60126

  • PRINCIPAL DISPLAY PANEL - 3 Topical Patch Carton

    NDC 50682 527 03

    GET PAIN
    RELIEF NOW!

    LidoPatch®

    CONTAINS LIDOCAINE
    PAIN
    RELIEF
    PATCH

    ✔
    SAME ACTIVE INGREDIENT AS
    LEADING PRESCRIPTION PATCH
    ✔
    ONE PATCH FOR 24 HOUR PAIN RELIEF
    ✔
    FOR RELIEF OF LOCALIZED PAIN
    ✔
    FAST ACTING
    ✔
    ULTRA THIN, FLEXIBLE, TRIM TO FIT

    3 TOPICAL PATCHES PER BOX

    Principal Display Panel - 3 Topical Patch Carton
  • INGREDIENTS AND APPEARANCE
    LIDOPATCH  PAIN RELIEF
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50682-527
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine40 mg
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol50 mg
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Acrylamide (UNII: 20R035KLCI)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Urea (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50682-527-033 in 1 CARTON
    11 in 1 POUCH
    2NDC:50682-527-077 in 1 CARTON
    21 in 1 POUCH
    3NDC:50682-527-3030 in 1 CARTON
    31 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34802/01/2012
    Labeler - 3T Federal Solutions LLC (557502155)
    Establishment
    NameAddressID/FEIBusiness Operations
    Katecho139791743MANUFACTURE
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