HAND SANITIZER FRAGRANCE FREE- ethyl alcohol solution

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Swinton Avenue Trading LTD. Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic To decrease bacteria on the skin that could cause disease Recommended for repeated use if irritation or redness develops.  If condition persists for more than 72 hours consult a doctor.
Authorization status:
OTC monograph not final
Authorization number:
62440-701-86

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HAND SANITIZER FRAGRANCE FREE- ethyl alcohol solution

Swinton Avenue Trading LTD. Inc.

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.

----------

HighMark Foam Hand Sanitizer Fragrance Free

701.000/701AA

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

FLAMMABLE, keep away from fire and flame

For external use only

When using this product

do not use in or near eyes

Stop use and ask a doctor

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a poison control center.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water, Isopropyl Alcohol, PEG-12 Dimethicone, Glycerin, Caprylic/Capric Triglyceride, Isopropyl

Myristate

Additional rear label text for manual dispensers

HIGHMARK MANUAL DISPENSER REFILL

FOAM HAND SANITIZER

FRAGRANCE FREE

Distributed by: Office Depot, LLC

6600 N. Military Trail, Boca Raton, FL 33496 USA

Highmark is a trademark or requisted trademark of OMX, Inc.

©2021 Office Depot, LLC. All Rights Reserved/

Made in USA woth foreign and domestic materials

Questions? Call 1-877-674-0688

33.9 FL OZ (1000 mL)

L0019531BA/000/00

Alcohol permit SDS-MO-15036, DSP-MO-28, DSP-MO-34

Item 9607759

Additional rear label text for automated refill

HIGHMARK

AUTOMATED DISPENSER REFILL

FOAM HAND SANITIZER

FRAGRANCE FREE

Distributed by: Office Depot, LLC

6600 N. Military Trail, Boca Raton, FL 33496 USA

Highmark is a trademark or registered trade of OMX<inc.

© 2021 Office Depot, LLC. All Rights Reserved.

Made in USA with foreign and domestic materials

Question? Call 1-877-674-0688

L0019532BA

5000011620/000/00

Alcohol permit SDS-MO-15036, DSP-MO-28, DSP-MO-34

Item 9989288

principal display for Manual Dispenser Refill

MANUAL DISPENSER REFILL

FOAM HAND

SANITIZER

FRAGRANCE FREE

33.9 FL OZ (1000mL)

L0019531FA

5000011616/000/00

ITEM 9607759

principal display panel for automated dispenser refill

AUTOMATED DISPENSER REFILL

FOAM HAND

SANITIZER

FRAGRANCE FREE

33.9 FL OZ (1000 mL)

L0019532FA

5000011619/000/00

ITEM 9989288

HAND SANITIZER FRAGRANCE FREE

ethyl alcohol solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 2440 -70 1

Swinton Avenue Trading LTD. Inc.

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

70 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

PEG-12 DIMETHICO NE (UNII: ZEL54N6 W9 5)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10 N)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 2440 -70 1-

10 0 0 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

11/17/20 20

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

11/17/20 20

Labeler -

Swinton Avenue T rading LT D. Inc. (153531108)

Registrant -

Vi-Jon, LLC. (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n, LLC.

0 8 8 520 6 6 8

ma nufa c ture (6 2440 -70 1)

Revised: 12/2020

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