OTC Medication Information: BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE

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.


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
c
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE 26 mg in 1 mL
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
EDETATE DISODIUM
NONOXYNOL-9
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-255-06 120 mL in 1 BOTTLE, DISPENSING None
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 Operations
Pharma Pac, LLC 140807475 manufacture

Revised: 07/2010 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.