Label: CURIST LIDOCAINE MAXIMUM STRENGTH- lidocaine 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 July 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Lidocaine 4%

  • PURPOSE

    Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    Use

    temporarily relieves minor pain

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on raw surfaces, blistered areas, wounds or other damaged skin
    • with a heating pad
    • more than one patch on your body at a time
    • with other topical anagesics

    When using this product

    • use only as directed
    • avoid contact with the eyes
    • do not bandage tightly

    Stop use and ask a doctor if

    • pain, swelling, blistering or other irritation occurs where patch was applied
    • condition worsens
    • symptoms last more than 7 days
    • condition clears up and occurs again within a few days

    If pregnant or breastfeeding, 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older:
    • clean and dry the affected area
    • open pouch and remove one patch
    • remove the protective backing from the patch starting at the corner
    • apply sticky side of patch to affected area
    • reseal pouch containing unused patches after each use
    • use one patch for up to 12 hours
    • discard patch after single use
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store in a clean, dry place outside of direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylic adhesive, alcohol, black pepper extract

  • QUESTIONS

    Questions?

    1-844-243-1241

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Little Pharma, Inc.

    New York, NY 10023

    Made in USA With Globally Sourced Ingredients

  • PRINCIPAL DISPLAY PANEL

    Curist

    Lidocaine Patch Maximum Strength

    Lidocaine 4% Patch

    Topical Anesthetic

    Temporary relief of pain: back, neck, shoulders, knees, elbows

    20 PATCHES

    3 in x 5 in (7.6 cm x 12.7 cm) each

    Lidocaine Patch 01-2022

  • INGREDIENTS AND APPEARANCE
    CURIST LIDOCAINE   MAXIMUM STRENGTH
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BLACK PEPPER (UNII: KM66971LVF)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-016-1920 in 1 POUCH01/24/2022
    12.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/24/2022
    Labeler - Little Pharma, Inc. (074328189)
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