SBS ULTRAPINK - triclosan gel 
Deb USA, Inc.

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, 0.15%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

Avoid contact with eyes

Keep out of reach of children

Consult with a physician or poison control center if ingested

Directions

Apply soap to dry hands

Add water

Lather for 15-20 seconds

Rinse and dry

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Sodium Chloride, Chloroxylenol, Acrylic Copolymer, Tetrasodium EDTA, Citric Acid, Glycol Distearate, Cocamide MEA, Sodium Hydroxide, Fragrance, Laureth-10, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Red 40 (CI16035).

SBS UltaPink

Pearlescent Antibacterial Gel

Ideal for Healthcare, Food Services, Office Environments, Schools, Professional Buildings

Proudly made in the USA

77127-01-116

1 Liter -  33.8 Fluid Ounces

container label

SBS ULTRAPINK 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-077-271000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 9/2010
Document Id: dbd8fc97-dc99-4924-9cc2-8fde2c282c5e
Set id: e0b49752-d697-4f93-bf37-a5918b229fb9
Version: 1
Effective Time: 20100909
 
Deb USA, Inc.