PROFORMANCE SERIES ANTIBACTERIAL  - triclosan liquid 
Pro-Link, 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, 0.30%

Purpose

Antibacterial

Uses

For hand washing to reduce bacteria on the skin

Warnings

For external use only

When using this product avoid contact with the eyes.

In case of eye contact, flush with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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Directions

Apply foaming cleanser to dry hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, PPG-24-Glycereth-24, Cocamidopropyl Betaine, Tetrasodium EDTA, 2-Bromo-2-nitropropane-1,3-diol, Fragrance, Citric Acid, Green 5 (CI 61570), Yellow 5 (CI 19140).

ProFormance Series

Antibacterial Foam Soap

Pro-Link

MA1000

Distributed exclusively by Pro-Link, Inc.

1 Liter

33.8 Fluid Ounces

container label

PROFORMANCE SERIES ANTIBACTERIAL  
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66908-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.30 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66908-053-271000 mL in 1 BOTTLE, PLASTIC
2NDC:66908-053-121200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2011
Labeler - Pro-Link, Inc. (144650637)
Registrant - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 1/2011
Document Id: 4af4e49c-7792-42fc-a33b-55eb38948c28
Set id: f4363ad3-8378-44ab-9396-718f435bbcd2
Version: 3
Effective Time: 20110103
 
Pro-Link, Inc.