ANTISEPTIC- benzalkonium chloride liquid

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Benzalkonium Chloride
Antiseptic towelette

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

• Antiseptic cleansing of face, hands and body to decrease bacteria on skin 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 doctor if irritation or redness develop 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 without wiping.

Inactive ingredients

purified water, alcohol

PRINCIPAL DISPLAY PANEL – pouch label

Safetec

Benzalkonium Chloride
Antiseptic
Towelette

For Professional and Hospital Use

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL – box label

NDC: 61010-7110-1

Safetec

Benzalkonium Chloride
Antiseptic
Towelette

For Professional and Hospital Use

Contents: 100 single-use, premoistened towelettes

Reorder No. 37400

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-7110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	1.30 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-7110-1	100 in 1 BOX
1	NDC: 61010-7110-0	0.0025 L in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/12/2011

Labeler - Safetec of America (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE