Cleanphirst Alcohol Free Antiseptic Hand Sanitizer

CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER - benzalkonium chloride gel
Cleanphirst, 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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Active Ingredient Purpose

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

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

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.

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

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

sanitizerdrugpanel

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.:

cleanphirstsanitizer1

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

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
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)

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

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

Labeler - Cleanphirst, LLC (833241438)

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