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

  • NDC Code(s): 69842-652-14, 69842-652-28
  • Packager: CVS Pharmacy
  • 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 October 29, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient (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

    CVS Health

    Antibacterial

    Lidocaine Wound Gel

    Lidocaine Hydrochloride

    Benzalkonium Chloride

    Antibacterial Gel with Pain Relief

    Helps prevent infection

    Antibiotic free

    For treating minor cuts, scrapes and burns

    Water-based clear hydrogel

    Helps reduce scarring

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LIDOCAINE WOUND GEL 
    benzalkonium chloride, lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-652
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-652-141 in 1 CARTON10/28/2019
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69842-652-281 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 not finalpart333A10/28/2019
    Labeler - CVS Pharmacy (062312574)