Label: BACTINE MAX LIDOCAINE ROLL-ON 2.5OZ- lidocaine liquid

  • NDC Code(s): 65197-840-25
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 25, 2023

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  • Active Ingredients (w/w)

    Lidocaine HCl 4%

  • Purpose 

    Topical anesthetic

  • Uses

    temporarily relieves minor pain 

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with the eyes
    • do not bandage or apply local heat (such as heating pads) to area of use

    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

    Flammable

    • keep away from fire or flame

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children and pets

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • adults and children 2 years of age and older:
    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • children 12 years or younger: ask a doctor
    • children under 2 years of age: do not use
  • Other information

    Store at room temperature

  • Inactive ingredients

    aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.

  • Questions?

    1-844-241-5454 or Bactine.com

  • Distributed by:

    WellSpring Pharmaceutical Corporation

    Sarasota, FL 34243

    © 2023 WellSpring Pharmaceutical Corporation

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    NO MESS MAX PAIN RELIEF WITH LIDOCAINE

    Numbs Away Pain and Itch

    Fast Acting

    For Pain, Minor Burns, Bug Bites & Sunburn

    Max Strength Lidocaine

    No Mess Applicator

    Fast Acting 

    With Aloe Vera

    Non-Greasy

    Quick Dry Formula

    HSA/FSA Eligible

    MONEY BACK GUARANTEE

    IMPORTANT:
    Keep this carton for future reference on full labeling.

    * Max Lidocaine HCL concentration per FDA External Analgesic OTC monograph

    NDC 65197-840-25CT84000A Bactine Max Roll-on Artwork

    Bactine Max Roll-on Artwork

    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 ROLL-ON 2.5OZ 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-840
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Product Characteristics
    Colorwhite (translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-840-251 in 1 BOX01/15/2024
    171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/15/2024
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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