Label: BACTINE MAX- lidocaine liquid

  • NDC Code(s): 65197-832-03
  • Packager: WellSpring Pharmaceutical Corporation
  • 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 February 23, 2022

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  • Active Ingredients (w/w)

    Lidocaine 4%

  • Purpose 

    External Analgesic

  • Uses

    For temporary relief of pain or discomfort in minor cuts, scrapes and burns.

  • Warnings

    For external use only

    Do not use

    • If you are allergic to any of the ingredients
    • in or near the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds
    • deep cuts
    • animal bites
    • serious burns

    When using this product

    • do not apply over raw surfaces or blistered areas

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and occur again within a few days

    Keep out of reach of children

    • If swallowed, call a poison control center or get medical help right away.
  • Directions

    • adults and children 2 years of age and older:
    • shake well
    • clean the affected area and apply a small amount up to 3 times daily and let dry 
    • a second coating may be applied for extra protection 
    • children under 2 years of age: ask doctor prior to use
  • Other information

    Store at room temperature

  • Inactive ingredients

    acrylates copolymer, alcohol denat, ammonium acrylates copolymer, benzalkonium chloride, disodium deceth-6 sulfosuccinate, disodium EDTA, laureth-30, propanediol, sodium dehydroacetate, water

  • Questions?

    1-844-241-5454 or Bactine.com

  • Distributed by:

    *Germs commonly associated with skin infections.

    Distributed by:

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243

    © 2022 WellSpring Pharmaceutical Corporation
    MONEY BACK GUARANTEE

    Bactine Max is FSA/HSA eligible.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    New

    Bactine Max

    Liquid Bandage with Lidocaine

    Max Pain Relief

    Kills 99% of Germs 

    Invisible Protection 

    Relieves    Kills     Protects

    NO STING 

    SHAKE WELL

    Bactine Max Liquid Bandage with Lidocaine - Box

    Bactine Max Liquid Bandage with Lidocaine

    Back Panel

    New

    Bactine Max

    Liquid Bandage with Lidocaine

    SHAKE WELL

    Bactine Max Liquid Bandageʼs unique formula provides maximum strength pain relief with LIDOCAINE, kills 99.9% of germs*, and protects hard-to-cover minor cuts and scrapes. This flexible bandage dries clear quickly and is breathable to maximize healing.

  • INGREDIENTS AND APPEARANCE
    BACTINE MAX 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-832
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAURETH-30 (UNII: W9D845551A)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-832-031 in 1 BOX04/01/2022
    110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2022
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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