BORTEK FOAMING HAND SANITIZER- benzalkonium chloride liquid

Bortek Foaming Hand Sanitizer by

Drug Labeling and Warnings

Bortek Foaming Hand Sanitizer 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 decrease bacteria on the skin that can potentially cause disease.
• Recommended for repeated use.

Warning

• 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.

When using

For external use only. Keep out of eyes, ears or mouth.

Safety information

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

Children

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

Directions

• Pump sufficient amount of foam into palm of hand.
• Wet all surfaces of both hands thoroughly with product, including area under the finger nails until dry.

Inactive ingredient

Cetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.

Bortek single label

Rev 1.0                                  A FAMILY COMPANY SINCE 1967                    800.626.7835

Part #: 5072-Bortek                                                                                         sweeperland.com

Bortek®

INDUSTRIES, INC.

ALCOHOL-FREE FOAMING HAND SANITIZER

KILLS 99.99% OF GERMS                                                                               MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE®

Drug Facts
Active Ingredient                                             Purpose Benzalkonium Chloride 0.1% w/w………Antiseptic	Directions Pump sufficient amount of foam into palm of hand. Wet all surfaces of both hands thoroughly with product, including area under the finger nails until dry.
Uses Handwash to decrease bacteria on the skin that can potentially 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.	Inactive Ingredients Cetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.
Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130110             Net Contents: 1000 ml

Bortek case label

Rev 1.0                                  A FAMILY COMPANY SINCE 1967                    800.626.7835

Part #: 5072-Bortek                                                                                         sweeperland.com

Bortek®

INDUSTRIES, INC.

ALCOHOL-FREE FOAMING HAND SANITIZER

KILLS 99.99% OF GERMS                                                                               MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE®

Corporate Headquarters

4713 Gettysburg Road

Mechanicsburg, PA 17055

EQUIPMENT       PARTS   RENTALS              SERVICE               SUPPLIES

Drug Facts
Active Ingredient                                             Purpose Benzalkonium Chloride 0.1% w/w………Antiseptic Uses Handwash to decrease bacteria on the skin that can potentially 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 Pump sufficient amount of foam into palm of hand. Wet all surfaces of both hands thoroughly with product, including area under the finger nails until dry.	Inactive Ingredients Cetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.
Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130110             Net Contents: 6 x 1000 ml

INGREDIENTS AND APPEARANCE

BORTEK FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-403
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-403-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-403-02	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(58575-403)