Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

reduces amount of bacteria on hands

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance

Case Label - 8 x 1000 mL Bags

FOAM-BAC ANTIBACTERIAL HAND
benzalkonium chloride soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)

Product Characteristics
Color	white (colorless, water-white (dispensed as a white foam))	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65585-521-01	8 in 1 BOX	04/26/2021
1		1000 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:65585-521-02	6 in 1 BOX	04/26/2021
2		550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	04/26/2021

Labeler - Whisk Products, Inc. (834270639)

Name	Address	ID/FEI	Business Operations
Establishment
Whisk Products, Inc.		834270639	manufacture(65585-521)