KLAR AND DANVER ANTIBACTERIAL HAND - benzalkonium chloride soap
Greenbrier International, 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.

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KLAR & DANVER ANTIBACTERIAL LIQUID HAND SOAP

Active Ingredient

Benzalkonium Chloride 0.10%

Purpose

Antibacterial

Use:

Handwashing to decrease bacteria on skin.

Warnings:

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develop or increase.

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

Directions:

Wet hands, work into a rich lather
Rinse well.

Inactive Ingredients:

WATER, SODIUM LAURYL ETHER SULFATE, COCAMIDOPROPYL BETAINE, SODIUM CHLORIDE, POLYQUATERNIUM-7, FRAGRANCE, METHYLISOTHIAZOLINONE, METHYLCHLOROISOTHIASOLINONE, CITRIC ACID, GLUTARIC DIALDEHYDE, TETRASODIUM EDTA, TOCOPHERYL ACETATE (VITAMIN E), ALOE BARBADENSIS LEAF EXTRACT, FD C ORANGE 7 (CI 15510).

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN MEXICO

KLAR & DANVER ANTIBACTERIAL LIQUID HAND SOAP 1,584 Bottles (443ml each) (33992-8000-0)

KLAR AND DANVER ANTIBACTERIAL HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:33992-8000
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SODIUM LAURYL SULFATE
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
METHYLISOTHIAZOLINONE
METHYLCHLOROISOTHIAZOLINONE
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
D&C ORANGE NO. 4

#	Item Code	Package Description
Packaging
1	NDC:33992-8000-0	1584 in 1 CONTAINER
1		443 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/28/2013

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
4e De Mexico SA de CV		813022811	manufacture(33992-8000)

Revised: 9/2013

Document Id: 7fbd3c2e-8428-41a7-a429-f7fe75c5b1ff

Set id: b91264a5-8e8f-4280-9097-256e3c345797

Version: 2

Effective Time: 20130904

Greenbrier International, Inc.