Label: MERICAINE- lidocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 13, 2019

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  • Drug Facts Lidocaine 4% Gel

    Active Ingredient

    Lidocaine 4% w/w

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
  • Warnings

    For external use only.  Not for ophthalmic use.

  • Do not use:

    • in or near the eyes
    • in large quantities, particularly over raw surfaces or blistered areas
  • Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years and older:  Apply externally to the affected area up to 3 to 4 times a day.
    • Children under 2 years of age:  Consult a doctor.
  • Inactive Ingredients

    alcohol, benzyl alcohol, carbomer, citric acid, ethoxydiglycol, propylene glycol, and purified water.

  • Other Information

    • May be applied under occlusive dressing.
    • Store at 25 ​0​C (77 ​0​F); excursions permitted to 15-30 ​0​C (59-86 ​0​F) [See USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MERICAINE 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30727-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30727-810-301 in 1 BOX07/01/2016
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2015
    Labeler - Merit Pharmaceutical (093370369)
    Registrant - Merit Pharmaceutical (093370369)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biozone Laboratories, Inc.962455320manufacture(30727-810) , analysis(30727-810) , pack(30727-810) , label(30727-810)
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