E3 HAND SANITIZER- benzalkonium chloride liquid 
Seatex Ltd

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................Purpose

Benzalkonium Chloride 0.1%................Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin.
Recommended for repeated use.

Warnings


For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

Directions

  • Pump a small amount of foam into palm of hand.
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry.

Inactive Ingredients

WATER,DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE,GLYCERETH-2 COCOATE,BEHENTRIMONIUM CHLORIDE,DIHYDROXYETHYL COCAMINE OXIDE.

Manufactured by Seatex Ltd, Rosenberg,Texas 77471


label
cbi label




E3  HAND SANITIZER
e3 foaming hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
WATER 
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE 
DIHYDROXYETHYL COCAMINE OXIDE 
GLYCERETH-2 COCOATE 
BEHENTRIMONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:76250-110-013.78 kg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/2011
Labeler - Seatex Ltd (026647404)
Registrant - Seatex Ltd (026647404)
Establishment
NameAddressID/FEIBusiness Operations
Seatex Ltd026647404manufacture

Revised: 09/2011
Document Id: 20ad2ef7-f5a5-4fa3-bd4d-1c51cf6579d9
Set id: 6f07564b-ba6d-48c3-aaf4-7e14f1b38524
Version: 1
Effective Time: 20110915
 
Seatex Ltd