Label: BACTINE MAX- benzalkonium chloride and lidocaine hydrochloride liquid

  • NDC Code(s): 65197-811-14, 65197-811-15
  • 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 24, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
     Benzalkonium Cl 0.13% w/w First aid antiseptic
     Lidocaine HCl 4% w/w Pain relieving spray
  • Uses

    first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

    • cuts
    • scrapes
    • minor burns
    • sunburn
    • minor skin irritations
  • Warnings

    For external use only

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use in or near the eyes
    • do not apply over large areas of the body or in large quantities
    • 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, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
    • children under 2 years, ask a doctor
  • Other information

    avoid excessive heat

  • Inactive ingredients

    edetate disodium, fragrances, propylene glycol, purified water

  • Questions?

    1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com


  • SPL UNCLASSIFIED SECTION

    Money Back Guarantee

    Manufactured for: WellSpring, Sarasota, FL 34243

    ©2018

    *germs commonly associated with skin infections.

  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

    First Aid Pain Reliever & Antiseptic

    Kills 99% of Germs*

    Max Strength Germ Killing

    4% Lidocaine HCL

    Max Strength Pain Reliever

    No Sting

     5 FL OZ (148 mL)

    Front Bottle Label
  • DRUG FACTS LABEL

    Bottle Label (Back)
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    First Aid Pain Reliever & Antiseptic

    Kills 99% of Germs*

    Max Strength Germ Killing

    4% Lidocaine HCL

    Max Strength Pain Reliever

    No Sting

     4 FL OZ (118 mL)

    First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)

    Rear Label

  • INGREDIENTS AND APPEARANCE
    BACTINE MAX 
    benzalkonium chloride and lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-811
    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 ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-811-15148 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
    2NDC:65197-811-14118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2018
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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