BACTINE PAIN RELIEVING- 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® Pain Relieving Cleansing Spray

Drug Facts

Active ingredients	Purpose
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)

BACTINE PAIN RELIEVING
benzalkonium chloride and lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65197-812
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65197-812-04	148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/16/2015	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333A	12/16/2015	12/31/2021

Labeler - WellSpring Pharmaceutical Corporation (110999054)

Revised: 1/2020

Document Id: 87acf15c-63a6-4d7d-a132-111074b0a5fd

Set id: ea1ad81e-b658-4ba8-b78e-6acbfb9a8622

Version: 9

Effective Time: 20200117

WellSpring Pharmaceutical Corporation