BORTEK E-3- foaming hand sanitizer liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Inopak, Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - 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.
Authorization status:
OTC monograph not final
Authorization number:
58575-203-01, 58575-203-02

BORTEK E-3- foaming hand sanitizer liquid

Inopak, 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.

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Bortex E-3 Hand Sanitizer 203

Active Ingredient

Ethyl Alcohol 70%

Purpos e

Antiseptic

Us es

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

Purpos e

Ethyl Alcohol 70% v/v……………………………

Antiseptic

Us es

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

Us es

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

BORTEK E-3

foaming hand sanitizer liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-20 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

CHLO RHEXIDINE GLUCO NATE (UNII: MOR8 4MUD8 E)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

PEG-14 1-( ( METHYLPHENYL) ETHYL) PHENYL ETHER AMMO NIUM SULFATE (UNII: S4S9 78 3N13)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Inopak, Ltd

PO LYQ UATERNIUM-10 ( 10 0 0 MPA.S AT 2 %) (UNII: GMR4PEN8 PK)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:58 575-20 3-

10 0 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 18

2

NDC:58 575-20 3-

6 0 0 0 mL in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 1/0 1/20 18

Labeler -

Inopak, Ltd (194718243)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ino pak, Ltd

19 4718 243

ma nufa c ture (58 575-20 3)

Revised: 10/2019

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