CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER- benzalkonium chloride gel

CLEANpHIRST Alcohol Free Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

CLEANpHIRST Alcohol Free Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cleanphirst, LLC, MicroPure Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                              Purpose

Benzalkonium Chloride 0.13 percent.............................Antiseptic

PURPOSE

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS

Warnings:

For external use only.

Do not use in the eyes.

Discontinue if irritation or redness develop.

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.

DOSAGE & ADMINISTRATION

Directions: Wet hands thoroughly with product and allow to dry without wiping.

INACTIVE INGREDIENT

Inactive Ingredients: Behentrimonium Chloride, Citric Acid, Dihydroxyethyl Cocamine Oxide, Dihydroxpropyl PEG-5, Linoleammonium Chloride, Fragrance, Glycereth-2 Cocoate, Glycerin, Potassium Carbonate, Water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

CLEANpHIRST

Alcohol Free

Antiseptic Hand Sanitizer

Kills up to 99.999 percent of germs

 leaves skin soft

Won't Dry Out Hands

www.cleanphirst.com

125 Applications/1.7fl oz (50mL)

 Manufactured by: MicroPure Solutions, LLC

1055 Stevenson Ct., Suite 15 W

 Roselle, IL 60172

United States   

Exp. Date:

 Lot No.:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52138-100
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CARBONATE (UNII: BQN1B9B9HA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52138-100-50	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	05/12/2010

Labeler - Cleanphirst, LLC (833241438)

Establishment
Name	Address	ID/FEI	Business Operations
MicroPure Solutions, LLC		805764508	manufacture