ANTIBACTERIAL- antibacterial liquid 
Topco Associates 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

Active Ingredient

Triclosan 0.14%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Cocoamidopropyl Betaine, Sodium Lauryl Ether Sulphate, Coconut Acid Diethanol Amide, PEG-40 Castor Oil, Sodium Chloride, Phenoxyethanol, Fragrance, Citric Acid, Ethylenediaminetetraacetic Acid Disodium Salt, PEG-600 Stearate, Red 4(C.I. 14700)

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT RD.
SKOKIE, IL 60077
MADE IN CHINA
© TOPCO JPC1106

Principal Display Panel – Floral Bottle Label

VALU TIME
antibacterial
Hand Soap
FLORAL
11.5 FL OZ (340mL)

Principal Display Panel – Floral Bottle Label

Principal Display Panel – Herbal Bottle Label

VALU TIME
antibacterial
Hand Soap
HERBAL
11.5 FL OZ (340mL)

Principal Display Panel – Herbal Bottle Label

Principal Display Panel – Natural Bottle Label

VALU TIME
antibacterial
Hand Soap
NATURAL
11.5 FL OZ (340mL)

Principal Display Panel – Natural Bottle Label
ANTIBACTERIAL 
antibacterial liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
sodium chloride (UNII: 451W47IQ8X)  
phenoxyethanol (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-101-01340 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2006
ANTIBACTERIAL 
antibacterial liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
sodium chloride (UNII: 451W47IQ8X)  
phenoxyethanol (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-102-01340 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2006
ANTIBACTERIAL 
antibacterial liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan0.476 mL  in 340 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
sodium chloride (UNII: 451W47IQ8X)  
phenoxyethanol (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-103-01340 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2006
Labeler - Topco Associates LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
BBC Group Limited421270060MANUFACTURE

Revised: 9/2011
Document Id: a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095
Set id: 3b4cb539-463f-4cfd-95c0-e8a76dfe5041
Version: 1
Effective Time: 20110914
 
Topco Associates LLC