Label: BACTINE MAX DRY- lidocaine hydrochloride spray

  • NDC Code(s): 65197-815-04
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL

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 December 27, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Pain Relieving Spray 

  • Uses

    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

  • Warnings

    For external use only

    Do not Use

    ■ in large quantities, particularly over raw surfaces or blister areas

    ■ on puncture wounds

    ■ in or near the eyes 

    ■ longer than 1 week unless directed by a doctor

    When using this product

    ■ use only as directed. Read and follow all directions and warnings on this label. 

    ■ do not allow contact with the eyes and mucous membranes

    ■ avoid spraying on face

    ■ avoid inhalation of spray

    ■ do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

    ■ do not use at the same time as other topical analgesics

    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

    Extremely Flammable

    ■ do not use near heat or flame or while smoking

    ■ avoid long term storage above 104°F (40°C) 

    ■ do not puncture or incinerate. Contents under pressure.

    ■ do not store at temperatures above 120°F (49°C)

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    ■ adults and children over 12 years:

    ■ spray affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24 hour period

    ■ product will dry quickly on its own, and does not need to be rubbed in

    ■ children 12 years or younger: ask a doctor

  • SAFE HANDLING WARNING

    Child-resistant packaging. Replace cap after each use

  • Inactive ingredients

    alcohol denat. (28 %)

    anthemis nobilis flower oil

    aqua

    arnica montana flower extract

    calendula officinalis flower extract

    Caprylic/Capric Triglyceride

    glycerin

    isobutane

    propylene glycol

  • Questions?

    1-844-241-5454 or www.bactine.com

  • Distributed by:

    WellSpring Pharmaceutical Corporation

    Sarasota, FL 34243

    ©2022 Wellspring

    Pharmaceutical Corporation

    MONEYBACK GUARANTEE

    Bactine max is FSA/HSA eligible

    DOT 2Q M5706

    Extremely Flammable

  • PRINCIPAL DISPLAY PANEL

    NEW

    NDC 65197-815-04

    Bactine MAX

    LIDOCAINE Dry Spray

    Anesthetic

    NUMBS AWAY PAIN AND ITCH

    MAX RELIEF FOR Minor Cuts & Scrapes, Burns, Bug bites & Sunburn

    QUICK-DRY

    4oz (175mL)

    Artwork

    Bactine Dry Spray 4oz

  • INGREDIENTS AND APPEARANCE
    BACTINE MAX DRY 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-815-04175 mL in 1 CAN; Type 0: Not a Combination Product01/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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