KLAR AND DANVER ANTIBACTERIAL HAND- benzalkonium chloride soap

KLAR and DANVER ANTIBACTERIAL HAND by

Drug Labeling and Warnings

KLAR and DANVER ANTIBACTERIAL HAND by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., 4E Global, S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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

KLAR and DANVER ANTIBACTERIAL LIQUID HAND SOAP 1,210 Bottles (591ml each) (33992-8000-1)

INGREDIENTS AND APPEARANCE

KLAR AND DANVER ANTIBACTERIAL HAND  
benzalkonium chloride soap

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8000-0	1584 in 1 CONTAINER	08/28/2013
1		443 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 33992-8000-1	1210 in 1 CONTAINER	08/28/2013
2		591 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Greenbrier International, Inc. (610322518)

Registrant - 4E Global, S.A.P.I. de C.V. (812821307)

Establishment
Name	Address	ID/FEI	Business Operations
4E Global, S.A.P.I. de C.V.		812821307	manufacture(33992-8000)