E3 Hand Sanitizer: Package Insert and Label Information

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.

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

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cbi label
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labelcbi label
E3 HAND SANITIZER
e3 foaming hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76250-110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 g in 1 kg
Inactive Ingredients
Ingredient Name Strength
WATER
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE
DIHYDROXYETHYL COCAMINE OXIDE
GLYCERETH-2 COCOATE
BEHENTRIMONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76250-110-01 3.78 kg in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/15/2011
Labeler — Seatex Ltd (026647404)
Registrant — Seatex Ltd (026647404)
Establishment
Name Address ID/FEI Operations
Seatex Ltd 026647404 manufacture

Revised: 09/2011 Seatex Ltd

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