BACTINE ORIGINAL FIRST AID- benzalkonium chloride and lidocaine hydrochloride liquid

Bactine Original First Aid by

Drug Labeling and Warnings

Bactine Original First Aid by is a Otc medication manufactured, distributed, or labeled by WellSpring Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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

INGREDIENTS AND APPEARANCE

BACTINE ORIGINAL FIRST AID 
benzalkonium chloride and lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65197-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
NONOXYNOL-9 (UNII: 48Q180SH9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65197-810-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2015	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	12/16/2015	04/01/2021

Labeler - WellSpring Pharmaceutical Corporation (110999054)