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

  • 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 C 14-16 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68604-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68604-023-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/201309/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/22/201309/05/2017
Labeler - Auto-Chlor System, LLC (965194330)
Establishment
NameAddressID/FEIBusiness Operations
Auto-Chlor Sytem, LLC965194330manufacture(68604-023)

Revised: 9/2017
Document Id: 5a42171b-dd84-7e5a-e053-2991aa0a3448
Set id: 1188d175-c217-4d63-881d-bdadeff90588
Version: 3
Effective Time: 20170928
 
Auto-Chlor System, LLC