BACTINE PAIN RELIEVING- benzalkonium chloride and lidocaine hydrochloride liquid

Bactine Pain Relieving by

Drug Labeling and Warnings

Bactine Pain Relieving 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 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)

INGREDIENTS AND APPEARANCE

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

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: 65197-812-04	148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/16/2015	12/31/2021

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

Labeler - WellSpring Pharmaceutical Corporation (110999054)