MUELLER INSTANT HAND SANITIZER (ALCOHOL) LIQUID [MUELLER SPORTS MEDICINE, INC.]

MUELLER INSTANT HAND SANITIZER (ALCOHOL) LIQUID [MUELLER SPORTS MEDICINE, INC.]
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NDC	52564-460-04
Set ID	196c0cda-59ca-41fd-81f5-93ce60318fb9
Category	HUMAN OTC DRUG LABEL
Packager	Mueller Sports Medicine, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333E

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PRINCIPAL DISPLAY PANEL

Ethyl Alcohol 62%

Antiseptic handwash

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Use for handwashing to decrease bacteria on the skin. recommended for repeated use

For external use only, Flammable, keep away from fire or flame. When using this product do no tuse in the eyes. discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Directions. Wer hands thoroughly with product and allow to dry without wiping.

Other information. place a quarter size amount into one hand, spread over both hands to wrist and rub into skin until dry. Store at 59 to 77 degrees Farenheit (15 to 25 degrees Celsius)

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUELLER INSTANT HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52564-460
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52564-460-04	118 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/05/2010

Labeler - Mueller Sports Medicine, Inc. (006426316)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies, LLC		155522589	manufacture(52564-460)

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