STOKO REFRESH 4IN1 INSTANT HAND SANITIZER SP.- ethyl alcohol liquid

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Deb USA, Inc.
INN (International Name):
ALCOHOL
Composition:
ALCOHOL 70 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hand Antiseptic Decreases bacteria on the skin and reduces the risk of cross-infection.
Authorization status:
OTC monograph not final
Authorization number:
11084-964-43

STOKO REFRESH 4IN1 INSTANT HAND SANITIZER SP.- ethyl alcohol liquid

Deb USA, 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.

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Drug Facts

Active Ingredient

Ethanol (70%)

Purpos e

Hand Antiseptic

Us es :

Decreases bacteria on the skin and reduces the risk of cross-infection.

Warnings :

Flammable, For external use only.

Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.

Stop use and ask doctor if

Skin or eye irritation 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 an adequate amount, rubbing over all surfaces of both hands for at least 15 seconds. Allow to

dry without wiping.

Inactive Ingredients:

Deionized Water, Ethylcellulose.

STOKO Refresh®

INSTANT HAND SANITIZING SPRAY

NDC 11084-964-46

Bio Preferred.

Net Contents 16.91 fl. oz

CONTENU NET 500 ml

Manufactured in U.S.A.

Deb USA, Inc.

Charlotte, NC, 28217

1-800-248-7190 / stoko.debgroup.com/us

Stock # / No De

Stock: 35233

INSTANT HAND SANITIZING SPRAY

Instant Hand Sanitizing Spray

How To Install:

Align bottle in to dispenser. Press firmly into place until

pump clicks. Close cover. Press dispenser to prime.

To replace, push green tab up to release bottle.

Aligner la bouteille dans le distributeur:

L’insérer fermement en place jusqu’à ce que la pompe émette

un clic. Fermer le couvercle. Appuyer sur le distributeur pour

rendre la pompe prête a distribuer le produit. Pour remplacer,

appuyer sur la languette verte afin de dégager la bouteille.

Medical Ingredient: Ethanol 70% v/v

Recommended use or purpose:

For hand hygiene to decrease bacteria on skin.

Recommended Dose:

Use as part of your daily cleansing routine. Place two sprays in your palm.

Rub thoroughly until dry. Do not rinse or wipe off.

Risk Information:

For external use only. Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly

with water.

Discontinue use and consult a health care practitioner if irritation develops.

Flammable. Keep away from open flame and sources of heat. Keep out of reach of children. If

swallowed get medical help

or contact a Poison Control Center right away.

Non Medicinal Ingredients: Deionized Water, Ethylcellulose

Ingrédient médicinal:

Alcool éthylique 70 % v/v

Utilisation ou usage recommandé:

Pour l’hygiène des mains afin de diminuer la quantité des bactéries sur la peau.

Dose Recommandée:

Utiliser dans le cadre de votre routine de nettoyage quotidienne.

Vaporiser deux fois le produit dans la paume des mains.

Bien se frotter les mains jusqu’à ce qu’elles soient sèches. Ne pas rincer ni essuyer.

Information relative aux risques:

Pour usage externe seulement. Éviter le contact avec les yeux. En cas de contact

accidentel avec les yeux, les rincer à fond avec de l’eau.

En cas d’irritation, cesser l’utilisation et consulter un médecin.

Produit inflammable. Tenir à l’écart des flammes nues et des sources de chaleur.

Tenir hors de portée des enfants. Si le produit est ingéré, immédiatement obtenir de l’aide médicinal

ou communiquer avec un centre antipoison.

Ingrédients non médicinaux:

Eau déminéralisée, éthylcellulose.

STOKO REFRESH 4IN1 INSTANT HAND SANITIZER SP.

ethyl alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:110 8 4-9 6 4

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 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ETHYLCELLULO SE ( 50 MPA.S) (UNII: 6 I475159 RA)

Deb USA, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:110 8 4-9 6 4-

50 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 6 /0 1/20 14

12/31/20 22

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 6 /0 1/20 14

12/31/20 22

Labeler -

Deb USA, Inc. (607378015)

Registrant -

Deb-ST OKO USA, LLC (055861874)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aphena Pharma So lutio ns-Maryland LLC

8 29 739 8 33

ma nufa c ture (110 8 4-9 6 4)

Revised: 12/2018

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