BZK ANTISEPTIC- benzalkonium chloride swab 
Lights Medical Manufacture Co., Ltd.

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.

----------

61333-500 BZK Antiseptic Swab

Active ingredient

benzalkonium chloride 0.13%

Purpose

First aid antiseptic

Uses

Antiseptic cleaning of face, hands and body without soap and water.

Warnings

For external use only.

Do not use in the eyes.  If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours

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

Directions

Tear open packet, unfold and use as a washcloth. Allow hands to dry with wiping

Water

image description

BZK ANTISEPTIC 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61333-500-011 in 1 PACKAGE06/02/2021
10.4 mg in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/02/2021
Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
Establishment
NameAddressID/FEIBusiness Operations
Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-500)

Revised: 1/2023
Document Id: f26664cf-8ab5-7556-e053-2995a90a965c
Set id: 698ed472-9204-46e3-95a4-d59e204628ac
Version: 7
Effective Time: 20230116
 
Lights Medical Manufacture Co., Ltd.