BORTEK E-3- foaming hand sanitizer liquid

Bortek E-3 by

Drug Labeling and Warnings

Bortek E-3 by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.
• Recommended for repeated use.

Warnings

• For external use only. Keep out of eyes, ears, or mouth.
• Discontinue use if irritation occurs.
• Keep out of reach of children.

FLAMMABLE, KEEP AWA FROM FIRE OR FLAME.

When Using

Keep out of eyes, ears, or mouth.

Stoppage

• Discontinue use if irritation occurs.

Children

• Keep out of reach of children.

Directions

• If hands are visibly soiled, was with soap and water and dry hands.
• Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Amount of product into cupped palm of hand.

• Wash both hands thoroughly for 15 seconds. Rinse under running water and dry thoroughly.

Inactive Ingredients

benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

Bortek single label

Rev 1.0                                                  A FAMILY COMPANY SINCE 1967                800.626.7835

Part #: 5068-Bortek-CS                                                                                          sweeperland.com

Bortek®

INDUSTRIES, INC.

E-3 FOAMING HAND SANITIZER

                                                                                                                            MADE IN THE USA

YOUR CLEANING SOLUTIONS RESOURCE®

• Drug Facts Active Ingredient Purpose Ethyl Alcohol 70% v/v……………………………Antiseptic Uses For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment. Recommended for repeated use. Warnings For external use only. Keep out of eyes, ears, or mouth. Discontinue use if irritation occurs. Keep out of reach of children.:

  FLAMMABLE, KEEP AWA FROM FIRE OR FLAME.

  Directions

  • If hands are visibly soiled, was with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

  Inactive Ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

  Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130107                             Net Contents: 1000 ml

Bortek E-3 Foaming Hand Sanitizer case label

Rev 1.0                                                  A FAMILY COMPANY SINCE 1967                800.626.7835

Part #: 5068-Bortek-CS                                                                                          sweeperland.com

Bortek®

INDUSTRIES, INC.

E-3 FOAMING HAND SANITIZER

                                                                                                                              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 Ethyl Alcohol 70% v/v…………Antiseptic Uses For handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment. Recommended for repeated use. For external use only. Keep out of eyes, ears, or mouth.

Discontinue use if irritation occurs. Keep out of reach of children. FLAMMABLE, KEEP AWA FROM FIRE OR FLAME. Directions If hands are visibly soiled, was with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Amount of product into cupped palm of hand. Wash both hands thoroughly for 15 seconds. Rinse under running water and dry thoroughly. Inactive Ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water. Questions? Call 800.626.7835 or visit our website sweeperland.com

Reorder Item #: 28130107             Net Contents: 6 X 1000 ml              Does not contain DEA/MEA, triclosan,

                                                                                                         parabens, formaldehyde, dyes, or fragrance

INGREDIENTS AND APPEARANCE

BORTEK E-3 
foaming hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 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)
PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATE (UNII: S4S9783N13)
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: 58575-203-01	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-203-02	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(58575-203)