first depHense ALCOHOL-FREE Antiseptic Foam Hand Sanitizer

FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER - benzalkonium chloride liquid
First Dephense, 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.

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Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only.

Do not use in eyes. If contact occurs, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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

Directions

Pump a small amount of foam into palm of hand.
Wet hands thoroughly with product and allow to dry without wiping.
Rub hands together briskly until dry.

Inactive Ingredients

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

Distributed by first depHense, LLC
519 S. Main St., Sycamore, IL 60178

Made in USA.

NO RINSE
MOISTURIZES
LEAVES SKIN SOFT

Up To 3 Times MORE APPLICATIONS
THAN ALCOHOL-BASED GELS

first depHense
Protecting your health and environment

ALCOHOL-FREE
Antiseptic Foam Hand Sanitizer

Eliminates 99.999%
OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS

Environmentally Friendly
1.7 floz (50ml)

FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76116-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76116-100-01	50 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333E	01/13/2011

Labeler - First Dephense, LLC (028165717)

Name	Address	ID/FEI	Business Operations
Establishment
American Blending and Filling		809226710	manufacture