B4 Antiseptic Hand Sanitizer With Ethyl Alcohol (Ethyl Alcohol) Gel [Midway Advanced Products, Llc] -

B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL (ETHYL ALCOHOL) GEL [MIDWAY ADVANCED PRODUCTS, LLC]
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NDC	52490-201-10
Set ID	ac7d5bcd-95dd-449d-b26d-4f6abf7caa2b
Category	HUMAN OTC DRUG LABEL
Packager	Midway Advanced Products, LLC
Generic Name
Product Class
Product Number
Application Number	PART333E

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DRUG FACTS
Active ingredient

Ethyl Alcohol 65% w/w

Purpose

Antimicrobial
Uses
- to sanitize hands without water
- kills 99% of most common bacteria
Warnings
FLAMMABLE. For external use only.
When using this product:
- keep away from fire or flame
- do not use in eyes
- discontinue use if irritation or redness develop
Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- tear open packet and apply entire amount of gel to unsoiled hands
- rub in thoroughly until hands are dry
- do not wipe or use water rinse
Other information
- store at room temperature
Inactive ingredients

Water, Aloe Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C Yellow # 10, FD&C Yellow #5, FD&C Blue #1
Package Labeling

INGREDIENTS AND APPEARANCE

B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL
ethyl alcohol gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52490-201-10	500 in 1 CARTON	02/01/2018
1		1.2 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2018

Labeler - Midway Advanced Products, LLC (962765009)

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Medic