Label: MICROCAINE TOPICAL ANALGESIC- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • Drug Facts

  • Active Ingredient

    Lidocaine 5% w/w

    Purpose

    Local Anesthetic

  • Uses:

    Temporarily relieves pain from anorectal origin.

  • WARNINGS

    For External Use only

    When using this product

    • Do not get into the eyes
    • Do not use more than directed
    • Do not swallow

    Stop use and ask a doctor if

    • pain worsens or does not improve within 7 days or clears up and appears again in a few days
    • ​you develop an allergy

    Keep out of reach of children

    • If swallowed, get medical help right away or contact a Poison Control Center right away. NDC 67194-022-01
  • Directions:

    ​Children under 12 years-ask a doctor

    • Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.
  • Questions?

    ​Call toll free 888/452-4946

  • Inactive ingredients:

    Water (Aqua), Prolatum Oil. Stearyl Alcohol, Polysorbate 60, Cetearyl Alcohol, Glyceryl Stearate, Carbomer, Triethanolamine, Propylparaben, Propylene Glycol, Methylparaben, Disodium EDTA, Diazolidinyl Carbamide, BHT

  • ​Package Labeling:

    McaineMcaine2

  • INGREDIENTS AND APPEARANCE
    MICROCAINE TOPICAL ANALGESIC 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67194-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67194-022-0115 g in 1 JAR; Type 0: Not a Combination Product01/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/19/2016
    Labeler - Unit Dose, Ltd. (119080393)
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