EZ-SAN ANTI-BACTERIAL FOAM HAND- triclosan soap 
Vectair Systems, 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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Active Ingredient

Triclosan 0.3% w/w

Purpose

Skin Antimicrobial

Use

Reduces amount of bacteria on hands.

Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation & redness develop.  If condition persists for more than 72 hours, consult a physician.

For institutional & professional use only.

Not for use on children under six months of age.

Directions

  • Wet hands and forearms.
  • Apply a palmful to hands & forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, Sodium Cumenesulfonate, Sodium Chloride, Chloroxylenol, DMDM Hydantoin, Fragrance, Yellow 5, Blue 1

Case Label

EZ-SAN ANTI-BACTERIAL FOAM HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52007-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CUMENESULFONATE (UNII: 5798KA13PG)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorgreen (green (yellow-green) dispense as a white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52007-101-044 in 1 BOX04/22/201608/11/2018
11000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/22/201608/11/2018
Labeler - Vectair Systems, Inc. (805347296)

Revised: 12/2017
Document Id: 4199a5a6-005e-4693-9a89-c986c0918135
Set id: 64ad87e9-ab46-45ec-b6c7-8fe487448581
Version: 2
Effective Time: 20171221
 
Vectair Systems, Inc.