HAND KLEEN FOAMING ANTIBACTERIAL HAND- triclosan liquid
Auto-Chlor System, 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

Antiseptic handwash

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

For handwashing to decrease bacteria on the skin.

For external use only.

When using this product

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

Wet hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

Water, Sodium C 14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride, Glycerin, Lanolin, Sodium Xylenesulfonate, Tetrasodium EDTA, Citric Acid, Acid Blue 9, Acid Yellow 36, Fragrance

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image of case label

HAND KLEEN FOAMING ANTIBACTERIAL HAND
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68604-231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METANIL YELLOW (UNII: 7SPF5O5BW8)

Product Characteristics
Color	green (green (dispensed as a white foam))	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68604-231-02	4 in 1 BOX	12/17/2012	09/05/2017
1	NDC:68604-231-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/17/2012	09/05/2017

Labeler - Auto-Chlor System, LLC (965194330)

Name	Address	ID/FEI	Business Operations
Establishment
Auto-Chlor System, LLC		965194330	manufacture(68604-231)

Revised: 9/2017

Document Id: 5a443573-b45a-420e-e053-2a91aa0a1696

Set id: 3117562b-3e77-40fb-9dee-b38ecc237106

Version: 2

Effective Time: 20170928

Auto-Chlor System, LLC