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

Stoko Refresh 4in1 Instant Hand Sanitizer Sp. by

Drug Labeling and Warnings

Stoko Refresh 4in1 Instant Hand Sanitizer Sp. by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Deb-STOKO USA, LLC, Aphena Pharma Solutions-Maryland LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethanol (70%)

Purpose

Hand Antiseptic

Uses:

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.

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-964
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLCELLULOSE (50 MPA.S) (UNII: 6I475159RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-964-43	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2014	12/31/2022

Labeler - Deb USA, Inc. (607378015)

Registrant - Deb-STOKO USA, LLC (055861874)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions-Maryland LLC		829739833	manufacture(11084-964)