Label: LIDOCAINE HYDROCHLORIDE GEL- paraaid burn relief gel gel

  • 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 May 1, 2016

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  • DOSAGE & ADMINISTRATION

    MCURE HEALTH SOLUTIONS INC.

    20189 CURRIER ROAD, SUITE 200

    CITY OF INDUSTRY, CA 91789

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Lidocaine HCI 2.0% Topical Pain Relief

  • PURPOSE

    Uses
    Temporary pain relief for minor burns

  • INDICATIONS & USAGE


    Directions
    • Adults and children 2 years and older: apply 3 to 4 times daily
    • Children under 2: do not use, consult with a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

  • WARNINGS

    Warnings
    For external use only.
    Keep out of reach of childre.
    Do not use
    • near eyes, if this happens, rinse thoroughly with water
    • in large quantities, particularly over raw or blistered areas. Stop use, ask a doctor
    • if condition worsens or lasts more than 7 days or clears up and returns. If ingested, contact a poison control center directly

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    BURN GEL

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE GEL 
    paraaid burn relief gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 1342 (UNII: 809Y72KV36)  
    MENTHOL (UNII: L7T10EIP3A)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    PROPYLENE GLYCOL 1-BEHENATE (UNII: 293K4PAQ2T)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-008-020.9 g in 1 PACKET; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2016
    Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)
    Registrant - MCURE HEALTH SOLUTIONS INC. (053034873)
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