Label: LIDOCAINE gel

  • NDC Code(s): 71888-102-01, 71888-102-02
  • Packager: Bellus Medical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%

  • INACTIVE INGREDIENT

    Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.

  • DOSAGE & ADMINISTRATION

    USES: For the temporary relief of discomfort and pain associated with

    • Minor burns and skin irritations
    • Minor cuts and scrapes
    • Itching

    DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

  • WARNINGS

    WARNINGS: For external use only. Avoid contact with the eyes.

    DO NOT USE: In large quantities particularly over raw sources or blistered areas.

  • INDICATIONS & USAGE

    USES: For the temporary relief of discomfort and pain associated with

    • Minor burns and skin irritations
    • Minor cuts and scrapes
    • Itching

    DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

  • PURPOSE

    Topical Anesthetic

  • KEEP OUT OF REACH OF CHILDREN

    Keep put of reach of children.

  • PRINCIPAL DISPLAY PANEL

    BLT_4ml_Packet_L_170613 JPEG

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71888-102-0212 in 1 BOX06/01/2017
    1NDC:71888-102-014 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2017
    Labeler - Bellus Medical, LLC (005677967)
    Registrant - Bellus Medical, LLC (005677967)
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