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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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 C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Glycerin, Lanolin, Styrene / Acrylate Copolymer, Sodium Chloride, Fragrance


productlabel

image of product label

HAND KLEEN PREMIUM  ANTIBACTERIAL HAND
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68604-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (Triclosan) Triclosan0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium C14-16 Olefin Sulfonate 
Sodium Laureth Sulfate 
Lauryl Glucoside 
Cocamidopropyl Betaine 
Glycerin 
Lanolin 
Styrene 
Butyl Acrylate 
Sodium Chloride 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68604-023-013780 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2012
Labeler - Auto-Chlor System, LLC (965194330)
Establishment
NameAddressID/FEIBusiness Operations
Auto-Chlor Sytem, LLC965194330manufacture(68604-023)

Revised: 10/2012
Document Id: 817bbda6-b524-4f46-8f8b-6bed00481285
Set id: 1188d175-c217-4d63-881d-bdadeff90588
Version: 1
Effective Time: 20121001
 
Auto-Chlor System, LLC