ICING - hand sanitizer gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Yusef Manufacturing Laboratories, LLC
INN (International Name):
ALCOHOL
Composition:
ALCOHOL 0.62 g in 1 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose     Sanitizer
Authorization status:
OTC monograph not final
Authorization number:
10827-0003-1

ICING - hand sanitizer gel

Yusef Manufacturing Laboratories, LLC

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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Icing Hand Sanitizer - Aseptisant Pour Les Mains (Berry, Citrus, Clean)

Purpose Sanitizer

Instructions: Pour small amount of gel into the palm of your hands. Rub hands together until dry.

Mode d'emploi: Versez une petite quantite de gel au creux de vos mains. Frottez vos mains jusqu'a ce

qu'elles soient bien seches.

Warning: Flammable. Do not use near fire, flame or while smoking. Do not store where temperature

exceeds 120 F. For external use only. Avoid contact with eyes. In case of contact with eyes, flush

with water. Discontinue this product if rash, redness or irritation occurs. If irritation persists, get

immediate attention. Keep out of reach of children. DO NOT EAT.

Advertissement: Inflammable. Ne pas utiliser pres d'une fiamme, d'une etincelle ou en fumant. Ne

pas garder a des temperatures depassant les 49 C (120 F). Pour usage exteme uniquement. Evitez tout

contact avec les yeux. En cas de contact avec les yeux, rincez avec de l'eau. Arretez l'utilisation de ce

produit en cas d'irritation. Si l'irritation persiste, consulter immediatement un medecin. gardez hors de

portee des enfants. NE PAS INGERER.

Inactive Ingredients Water, Fragrance, Carbomer, Triethanolamine, Lactose, Microcrystalline

Cellulose, Ultramarines, Tocopheryl Acetate

Made in USA

CBI Distributing Corp. 2400 W. Central Road

Hoffman Estates, IL 60192-1930 U.S.A.

Enter section text here

Active Ingredient Ethyl Alcohol (62%)

Net Wt. 1 fl. oz. / (29ml)

ICING

Yusef Manufacturing Laboratories, LLC

hand sanitizer gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 8 27-0 0 0 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 .6 2 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CARBO MER HO MO PO LYMER TYPE C (UNII: 4Q9 3RCW27E)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

LACTO SE (UNII: J2B2A4N9 8 G)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

( PHTHALO CYANINATO ( 2 -) ) CO PPER (UNII: 3VEX9 T7UT5)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 8 27-0 0 0 3-1

28 g in 1 BOTTLE

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 rt333

0 3/10 /20 10

Labeler -

Yusef Manufacturing Laboratories, LLC (144150674)

Registrant -

Yusef Manufacturing Laboratories, LLC (144150674)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Yusef Manufacturing Labo rato ries, LLC

144150 6 74

ma nufa c ture

Revised: 3/2010

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