HAND KLEEN PREMIUM ANTIBACTERIAL HAND- 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.

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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


Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Tetrasodium EDTA, Anionic/Nonionic Detergent Blend, Glycerin, Sodium Chloride, Lanolin, Sodium Xylenesulfonate, Citric Acid, Fragrance


productlabel

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HAND KLEEN PREMIUM  ANTIBACTERIAL HAND
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68604-023
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 0.3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
Sodium Laureth Sulfate (UNII: BPV390UAP0)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Glycerin (UNII: PDC6A3C0OX)  
Lanolin (UNII: 7EV65EAW6H)  
Edetate Sodium (UNII: MP1J8420LU)  
Glycol Distearate (UNII: 13W7MDN21W)  
Sodium Chloride (UNII: 451W47IQ8X)  
Coco Monoethanolamide (UNII: C80684146D)  
Laureth-12 (UNII: OAH19558U1)  
Sodium Xylenesulfonate (UNII: G4LZF950UR)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68604-023-01 3780 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/22/2013
Labeler - Auto-Chlor System, LLC (965194330)
Establishment
Name Address ID/FEI Business Operations
Auto-Chlor Sytem, LLC 965194330 manufacture(68604-023)

Revised: 10/2012
Document Id: 96793af4-13d0-46af-ae70-d7d52c696a53
Set id: 1188d175-c217-4d63-881d-bdadeff90588
Version: 2
Effective Time: 20121001
 
Auto-Chlor System, LLC