B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL- ethyl alcohol gel
Midway Advanced Products, 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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b4 Antiseptic Hand Sanitizer with ethyl alcohol gel

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

B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52490-201
Route of Administration	TOPICAL

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)