CLAIRES- hand sanitizer gel

CLAIRES by

Drug Labeling and Warnings

CLAIRES by is a Otc medication manufactured, distributed, or labeled by Yusef Manufacturing Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Use     Decreases bacteria on hands

WARNINGS

Warnings     For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop.  If condition persists more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or call Poison Control Center immediately.  Store below 110 F (43 C).

SPL UNCLASSIFIED SECTION

Flammable     Keep away from fire or flame.

SPL UNCLASSIFIED SECTION

Directions     Rub a dime size drop into hands.

INACTIVE INGREDIENT

Inactive Ingredients     Water, Fragrance, Carbomer, Triethanolamine, Lactose, Microcrystalline Cellulose, Ultramarines, Tocopheryl Acetate

SPL UNCLASSIFIED SECTION

CBI Distributing Corp. 2400 W. Central Road
Hoffman Estates, IL  60192-1930   U.S.A. 

SPL UNCLASSIFIED SECTION

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CLAIRES 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10827-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
(PHTHALOCYANINATO(2-)) COPPER (UNII: 3VEX9T7UT5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10827-0002-1	28 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	01/15/2010

Labeler - Yusef Manufacturing Laboratories, LLC (144150674)

Registrant - Yusef Manufacturing Laboratories, LLC (144150674)

Establishment
Name	Address	ID/FEI	Business Operations
Yusef Manufacturing Laboratories, LLC		144150674	manufacture