BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE - benzalkonium chloride and lidocaine hydrochloride liquid 
CVS Pharmacy

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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drug facts



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



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. 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.


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 awayImmediately.


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


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BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE 
benzalkonium chloride and lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE26 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-255-06120 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333A07/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: c6e6e4ca-5c8f-494f-9499-e791571b82de
Set id: c5120583-0f3a-40c4-a20d-155d12044e7d
Version: 1
Effective Time: 20100708
 
CVS Pharmacy