ANTISEPTIC WIPE- benzalkonium chloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ashtel Studios Inc.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.133 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid antiseptic to help prevent skin infection in: - Minor Cuts - Scrapes - Burns - Antiseptic Cleasing - Perineal and maternity care Do not use - As an antiseptic for more than 1 week - In the eyes - Over large areas of the body Stop use - If irritation and redness develop - If condition persists more than 72 hours, consult a physician. Directions - Tear at notch - Remove towelette - Use only once As a first aid antiseptic - Clean affected area - Apply 1 to 3 times daily - May be covered with a sterile bandage - If bandaged, let dry first

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTISEPTIC WIPE- BENZALKONIUM CHLORIDE CLOTH
ASHTEL STUDIOS INC.
_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._
----------
Benzalkonium Chloride 0.13% v/v
Purpose
Antiseptic
First aid antiseptic to help prevent skin infection in:
Minor Cuts
Scrapes
Burns
Antiseptic Cleasing
Perineal and maternity care
For External Use Only.
Do not use
As an antiseptic for more than 1 week
In the eyes
Over large areas of the body
Ask a doctor before use if you have
Deep or pucture wounds
Animal bites
Serious burns
Stop use
If irritation and redness develop
If condition persists more than 72 hours, consult a physician.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center
right away.
Directions
Tear at notch
Remove towelette
Use only once
As a first aid antiseptic
Clean affected area
Apply 1 to 3 times daily
May be covered with a sterile bandage
If bandaged, let dry first
Other information
Store at room temperature
Avoid excessive heat
Inactive ingredients
Water
ANTISEPTIC WIPE
2in x 2.4in / 5cm x 6cm
ANTISEPTIC WIPE
benzalkonium chloride cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 10 8 -10 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .133 g
in 10 0 g
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:70 10 8 -10 0 -0 1
1.8 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 3/20 17
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
0 8 /0 3/20 17
Ashtel Studios Inc.
LABELER -
Ashtel Studios Inc.