OTC Medication Information: BZK Alcohol

BZK ALCOHOL — benzalkonium chloride swab
Wuxi Medical Instrument Factory

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.

Item# 83791-510-002 NDC#42947-610-02 Qty.1ea

BZK Alcohol Wash Towelette

Contains: Benzalkonium Chloride 0.13%

For Single Use Only

Caution: Keep out of reach of children

Manufactured by: Wuxi Medical Instrument Factory

No.86 East street, Zhangjing, Wuxi, Jiangsu 214194 China

Made in China

Active ingredient

Benzalkonium Chloride, 0.13% w/w

Purpose

First Aid Antiseptic

Use

First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns

Warnings For external use only. Do not use
In the eyes or apply over large areas of the body
longer than 1 week unless directed by a doctor.
In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult a doctor

if the condition persists or gets worse.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right way.

Directions

* Clean the affected area

* Apply a small amount of this product on the area 1 to 3 times daily

* May be covered with a sterile bandage when dry

Inactive ingredients

purified water, sodium bicarbonate, isopropyl alcohol


Image of Pouch Label

Pouch Label
(click image for full-size original)
BZK ALCOHOL
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42947-610
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.0013 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42947-610-02 1.4 mL in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 01/01/2009
Labeler — Wuxi Medical Instrument Factory (421292863)
Registrant — Wuxi Medical Instrument Factory (421292863)
Establishment
Name Address ID/FEI Operations
Wuxi Medical Instrument Factory 421292863 manufacture

Revised: 03/2001 Wuxi Medical Instrument Factory

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.

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