Bortek E-3 Hand Sanitizer

Bortek E-3 Foaming Hand Sanitizer by

Drug Labeling and Warnings

Bortek E-3 Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bortek Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BORTEK E-3 FOAMING HAND SANITIZER- ethanol liquid 
Bortek Industries

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.

----------

Bortek E-3 Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin after changing diapers, assisting ill persons or before contact with a person under medical care or treatment.

Warnings

For external use only.

Flammable, keep away from fire or flame

When using this product, keep away from eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a doctor if if irritation or redness develop or last more than 72 hours.

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

Directions

• Apply liberally to hands to cover all surfaces, including the area under the fingernails
• Rub hands together until dry

Inactive ingredients

Benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, phenoxyethanol, polyethylene oxid 600000, polyquaternium 10, water.

800.626.7835

BortekShop.com

Distributed by Bortek Industries, Inc., Mechanicsburg, PA 17055

Bortek® INDUSTRIES, INC.

Alcohol 70% Antiseptic

E-3 FOAMING HAND SANITIZER

33.8 fl oz (1000 mL)

BORTEK E-3 FOAMING HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81731-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81731-203-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/12/2021	04/27/2024
2	NDC: 81731-203-11	1000 mL in 1 POUCH; Type 0: Not a Combination Product	02/21/2022	04/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/12/2021	04/27/2024

Labeler - Bortek Industries (014184014)

Revised: 1/2023

Document Id: f278dd67-0c7a-39c5-e053-2995a90a9398

34390-5

Set id: bfcceb3d-4b06-5e3e-e053-2a95a90a46e1

Version: 4

Effective Time: 20230117