Label: ANTIBACTERIAL LIDOCAINE WOUND GEL- benzalkonium chloride, lidocaine hydrochloride gel

  • NDC Code(s): 59898-950-01, 59898-950-02
  • Packager: Water-Jel Technologies, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 28, 2024

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  • Active ingredients (in each gram)

    Benzalkonium Chloride 0.13%

    Lidocaine Hydrochloride 2.00%

  • Purpose

    first aid antiseptic

    external analgesic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

    For the temporary relief of pain associated with minor burns

  • Warnings

    For external use only

    Do not use

    in the eyes

    over large areas of the body, particularly over raw surfaces or blistered areas

    longer than a week unless directed by a doctor

    Ask a doctor before use if you have

    deep or puncture wounds

    animal bites

    serious burns

    Stop use and ask a doctor if

    the condition persists more than 7 days or gets worse

    Condition clears up and occurs again within a few days

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    clean the affected area

    adults and children 2 years of age and older:

    apply to affected area not more than 3 to 4 times daily

    children under 2 years of age: consult a doctor

    may be covered with a sterile bandage

    if bandaged, let dry first

  • Other information

    Store at room temperature

  • Inactive ingredients

    caprylyl glycol, chlorphenesin, edetate disodium, glycerin, hydroxyethyl cellulose, phenoxyethanol, polysorbate 20, purified water

  • Principal Display Panel

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LIDOCAINE WOUND GEL 
    benzalkonium chloride, lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Product Characteristics
    Colorwhite (Colorless, clear translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-950-011 in 1 CARTON10/28/2019
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:59898-950-021 in 1 CARTON10/28/2019
    228 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/28/2019
    Labeler - Water-Jel Technologies, LLC (155522589)
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