BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE liquid

BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE by

Drug Labeling and Warnings

BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                    Purpose
Benzalkonium Cl 0.13% w/w...............................Antiseptic
lidocaine HCl 2.5% w/w......................................Pain reliever

PURPOSE

Active ingredient                                    Purpose
Benzalkonium Cl 0.13% w/w...............................Antiseptic
lidocaine HCl 2.5% w/w......................................Pain reliever

Uses first aid to help prevent skin infection, and for temporary relief of pain
and itching associated with minor - cuts - scrapes - burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.

INDICATIONS & USAGE

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.

Uses first aid to help prevent skin infection, and for temporary relief of pain
and itching associated with minor - cuts - scrapes - burns

WARNINGS

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 awayImmediately.

DOSAGE & ADMINISTRATION

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 protect from excessive heat

INACTIVE INGREDIENT

Inactive Ingredients disodium EDTA, fragrance, nonoxynol-9, propylene glycol,
purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE 
benzalkonium chloride and lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	26 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	25 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-255-06	120 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	07/08/2010

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture