B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL- ethyl alcohol gel

b4 Antiseptic Hand Sanitizer with ethyl alcohol by

Drug Labeling and Warnings

b4 Antiseptic Hand Sanitizer with ethyl alcohol by is a Otc medication manufactured, distributed, or labeled by Midway Advanced Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2018

Labeler - Midway Advanced Products, LLC (962765009)