BACTINE ORIGINAL FIRST AID- benzalkonium chloride and lidocaine hydrochloride liquid 
WellSpring Pharmaceutical Corporation

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.

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Bactine® Original First Aid Liquid

Drug Facts

Active ingredientsPurpose
 Benzalkonium Cl 0.13% w/w First aid antiseptic
 Lidocaine HCl 2.5% w/w Pain relieving liquid

Uses

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

  • cuts
  • scrapes
  • burns

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 - 120 mL Bottle Label

Bactine®

NO STING

Original
First Aid Liquid

FIRST AID ANTISEPTIC & PAIN RELIEVER

Cleans • Soothes Instantly
Prevents Infection

4 FL OZ (120 mL)

Bactine 4 oz

Bactine 4 oz

BACTINE ORIGINAL FIRST AID 
benzalkonium chloride and lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-810
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:65197-810-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/201504/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A12/16/201504/01/2021
Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 12/2017
Document Id: 795aeedc-d984-47f5-8dd6-c789e645325b
Set id: b9ac2951-bf10-47e7-8e9d-7d6ceda701c5
Version: 8
Effective Time: 20171213
 
WellSpring Pharmaceutical Corporation