BORTEK E-2 FOAMING HAND WASH- benkalkonium chloride liquid

Bortek E-2 Foaming Hand Wash by

Drug Labeling and Warnings

Bortek E-2 Foaming Hand Wash by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium chloride

Purpose

Antiseptic

Uses

• Handwash to help reduce bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• For external use only.
• Keep out of eyes, ears, or mouth. In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours. If swallowed, get medical help or contact a Poison Control Center right away.

When Using

• In case of eye contact, flush eyes with water.

Stop use

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

Keep out reach of children

Keep out of reach of children.

Directions

• Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
• Rinse with water and towel dry.

Inactive Ingredient

Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.

Bortek E-2 hand wash single label

Rev 1.1                                                 A FAMILY COMPANY SINCE 1967               800.626.7835

Part#: 5064-Bortek                                                                                                          sweeperland.com

Bortek®

                                                INDUSTRIES, INC.

E-2 FOAMING HAND WASH

MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE

• Drug Facts Active Ingredient Purpose Benzalkonium chloride 0.13% w/w……..…Antiseptic Uses Handwash to help reduce bacteria on the skin that potentially can cause disease. Recommended for repeated use. Warnings For external use only. Keep out of eyes, ears, or mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation and redness develop 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

  • Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
  • Rinse with water and towel dry.

  Inactive Ingredients: Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.

  Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130106                                             Net Contents: 1000 ml

Bortek E2 Hand Wash Case label

Rev 1.0                                 A FAMILY COMPANY SINCE 1967               800.626.7835

Part#: 5064-Bortek                                                                                                          sweeperland.com

Bortek®

                                                INDUSTRIES, INC.

E-2 FOAMING HAND WASH

MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE

Corporate Headquarters

4713 Gettysburg Road

Mechanicsburg, PA 17055

Drug Facts Active Ingredient                                     Purpose              Benzalkonium chloride 0.13% w/w……Antiseptic Uses Handwash to help reduce bacteria on the skin that potentially can cause disease. Recommended for repeated use. Warnings For external use only. Keep out of eyes, ears, or mouth. In case of eye contact, flush eyes with water.	Stop use and ask a doctor if irritation and redness develop 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 Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds	Rinse with water and towel dry. Inactive Ingredients: Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.
Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130106                             Net Contents: 6 X 1000 ml

INGREDIENTS AND APPEARANCE

BORTEK E-2 FOAMING HAND WASH 
benkalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
METHYL ALCOHOL (UNII: Y4S76JWI15)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-401-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-401-02	6000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd. (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd.		194718243	manufacture(58575-401)