STOKO REFRESH FOAMING INSTANT HAND SANITIZER- ethyl alcohol liquid

Stoko Refresh Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

Stoko Refresh Foaming Instant Hand Sanitizer 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 (68%)

Purpose

Hand Antiseptic   

Uses

Hand antiseptic to decrease bacteria on the skin.

Warnings

Warnings

Flammable, For external use only. Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water. Discontinue use if irritation and redness develops.

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, Bis-PEG/PPG-20/20 Dimethicone, Ethylcellulose, PEG-14M.

PRINCIPAL DISPLAY PANEL

STOKO Refresh®
INSTANT HAND SANITIZING FOAM
NPN 80005750
NDC: 11084-960-28
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.
Alinee la botella en el aplicador
Presiónela firmemente en su lugar hasta que la bomba
haga “click”. Cierre la cubierta. Presione el aplicador para
cebar la bomba. Para reemplazar, presione la pestaña
verde para liberar la botella.
Bio Preferred.
Distributed by/Distribué par
Deb Canada
Waterford,ON N0E1Y0
1-888-332-7627
Net Contents 33.82 fl oz
CONTENU NET 1000 ml
Manufactured in U.S.A.
Fabriquée aux É.-U.
Deb USA, Inc.
Charlotte, NC, 28217
1-800-248-7190 / stoko.debgroup.com/us
Stock # / No De
Stock: 35231
INSTANT HAND SANITIZING FOAM
Medical Ingredient: Ethanol 68% v/v
Recommended use:
Hand Antiseptic. Kills harmful bacteria that can be found on the skin.
Recommended Dose:
Pump product into palm of hand and rub thoroughly until hands are dry. Do not rinse
or wipe off foam. Use as part of your daily cleansing routine.
Risk Information:
For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water.
Discontinue use and consult a health care practitioner if irritation develops.
Flammable. Keep away from open flame and sources of heat.
Non Medicinal Ingredients: Deionized Water, Bis-PEG/PPG-20/20 Dimethicone, Ethylcellulose, PEG-14M.
Ingrédient médicinal:
Éthanol 68 % v/v
Utilisation ou usage recommandé:
Antiseptique pour les mains. Élimine les bactéries nocives pouvant être présentes
sur la peau.
Dose Recommandée:
Enduire de produit la paume des mains et bien se frotter les mains
jusqu’à ce qu’elles soient sèches. Ne pas rincer ni essuyer la mousse. Utiliser le produit pour les
activités quotidiennes de désinfection anti-bactérienne
Information relative aux risques:
Pour usage externe seulement.
Éviter tout contact avec les yeux. En cas de contact, rincer les yeux a l’eau. Cesser
l’utilisation et consulter un médecin en cas d’irritation.
Produit inflammable. Tenir éloigné d’une flamme nue et de sources de chaleur.
Ingrédients non médicinaux: Eau déminéralisée, diméthicone bis-PEG/PPG-20/20, éthylcellulose, PEG-14M.

INGREDIENTS AND APPEARANCE

STOKO REFRESH FOAMING INSTANT HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-960
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BIS-PEG/PPG-20/20 DIMETHICONE (UNII: 05W209DSBS)
ETHYLCELLULOSE (50 MPA.S) (UNII: 6I475159RA)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-960-28	1000 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(11084-960)