HAND KLEEN SOUTHERN ORCHARDANTIBACTERIAL HAN ANTIBACTERIAL HAND CLEANSER- triclosan soap
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.

----------

DRUG FACTS

Triclosan 0.30% w/w

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 eyes thoroughly with water.

Directions

Wet hands and forearms.

Apply 5 mL or palmful to hand and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

Water, Sodium Laureth Sulfate, Sodium Chloride, Sodium C 14-16 Olefin Sulfonate, Glycerin, Tetrasodium EDTA, Lanolin, Sodium Xylenesulfonate, Dimethyloldimethyl Hydantoin, Citric Acid, Fragrance, Dye

Bottle label

HAND KLEEN SOUTHERN ORCHARDANTIBACTERIAL HAN ANTIBACTERIAL HAND CLEANSER
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68604-238
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 LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green (Light Green)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68604-238-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2014	09/05/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/04/2014	09/05/2017

Labeler - Auto-Chlor System, LLC (965194330)

Name	Address	ID/FEI	Business Operations
Establishment
Auto-Chlor System		965194330	manufacture(68604-238)

Revised: 9/2017

Document Id: 5a42171b-dd99-7e5a-e053-2991aa0a3448

Set id: 72fa5191-5a35-4731-937e-87eb1d533902

Version: 2

Effective Time: 20170928

Auto-Chlor System, LLC