BACTINE PAIN RELIEVING (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]

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BACTINE PAIN RELIEVING (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]
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NDC 65197-812-04
Set ID ea1ad81e-b658-4ba8-b78e-6acbfb9a8622
Category HUMAN OTC DRUG LABEL
Packager WellSpring Pharmaceutical Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
     Benzalkonium Cl 0.13% w/w First aid antiseptic
     Lidocaine HCl 2.5% 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
    • burns
    • sunburn
    • 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, nonoxynol 9, propylene glycol, purified water

  • Questions?

    1-844-241-5454  or www.bactine.com Money Back Guarantee

  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

    Bactine®

    NO STING

    Pain Relieving
    Cleansing Spray

    FIRST AID ANTISEPTIC & PAIN RELIEVER

    Cleans • Soothes Instantly
    Prevents Infection

    To unlock, push in tab and twist right.
    To lock, twist left until locked.

    5 FL OZ 
    (148 mL)

    Bottle Label
  • INGREDIENTS AND APPEARANCE
    BACTINE PAIN RELIEVING 
    benzalkonium chloride and lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-812
    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 ANHYDROUS2.5 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:65197-812-04148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/16/201512/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/16/201512/31/2021
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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