TRICLOSAN- triclosan liquid 
Columbia Jobbing

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

Active Ingredient:

Triclosan (0.35%)

Purpose:

Antiseptic Hand Cleanser

Uses

Warning

  • Keep out of reach of children.

Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

Other Information

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Cocamide DEA, Cocamidopropyl betaine, Sodium Cumene Sulfonate, Citric Acid, Fragrance, DMDM Hydantoin, Sodium Chloride, FD&C Green #3.

Principal Display Panel

Bio CLEAN

Foaming Antiseptic Hand Cleaner

A powerful antiseptic cleanser for handwashing

KEEP OUT OF REACH OF CHILDREN

CAUTION

See Drug Facts for panel for additional information.

Principal Display Panel
TRICLOSAN 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53119-575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.15 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium laureth sulfate (UNII: BPV390UAP0)  
sodium lauryl sulfate (UNII: 368GB5141J)  
propylene glycol (UNII: 6DC9Q167V3)  
lauric diethanolamide (UNII: I29I2VHG38)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
coco diethanolamide (UNII: 92005F972D)  
citric acid monohydrate (UNII: 2968PHW8QP)  
dmdm hydantoin (UNII: BYR0546TOW)  
sodium chloride (UNII: 451W47IQ8X)  
FD&C Green NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53119-575-201100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/11/2010
Labeler - Columbia Jobbing (032769788)
Registrant - Canberra Corporation (068080621)
Establishment
NameAddressID/FEIBusiness Operations
Canberra Corporation068080621MANUFACTURE(53119-575)

Revised: 9/2012
Document Id: 78e78f82-6420-4685-9d37-588346d05ef9
Set id: 7c149887-b375-46d4-ac78-4f838464111e
Version: 2
Effective Time: 20120912
 
Columbia Jobbing