BZK CLEANSING- benzalkonium chloride swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Family Hospitality LLC

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 1 mL in 750 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns - Antiseptic cleansing - Perineal and maternity care - deep or puncture wounds - animal bites - serious burns Stop Use if: - irritation and redness develop - if condition persists for more than 72 hours, consult a physician. Do not use - as a first aid antiseptic for more than 1 week - in the eyes - over large areas of the body

Authorization status:

OTC monograph not final

Summary of Product characteristics

BZK CLEANSING - BENZALKONIUM CHLORIDE SWAB
FAMILY HOSPITALITY LLC
_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._
----------
CLEANSING TOWELETTE
Active Ingredient Purpose
Benzalkonium Chloride 0.13% v/v Antiseptic
USE: CLEANSING TOWELETTE
First aid antiseptic to help prevent skin infection in minor cuts,
scrapes and burns
Antiseptic cleansing
Perineal and maternity care
WARNINGS
FOR EXTERNAL USE ONLY
INDICATIONS AND USAGE
General antiseptic
Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns
STOP USE IF
Stop Use if:
irritation and redness develop
if condition persists for more than 72 hours, consult a physician.
DIRECTIONS
Directions:
Tear at notch, remove towelette, use only once
As a first aid antiseptic
clean affeected area
apply 1 to 3 times daily
may be covered with a sterile bandage
if bandaged let dry first
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.
DO NOT USE
DO NOT USE
as a first aid antiseptic for more than 1 week
in the eyes
over large areas of the body
INACTIVE INGREDIENT SECTION
Inactive ingredient(s): water
PRINCIPAL DISPLAY PANEL
Cleansing towelette
Benzalkonium
CK_BZK.jpg
BZK CLEANSING
benzalkonium chloride swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:42738 -210
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Family Hospitality LLC
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
1 mL
in 750 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:42738 -210 -14
10 0 0 in 1 CASE
1
0 .55 mL in 1 POUCH
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE