FOAMY BLUE- benzalkonium chloride solution
Whisk Products, Inc.

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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Foamy Blue

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

Use

reduces amount of bacteria on hands

Warnings

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.

Directions

Apply a palmful to hands and forearms.
Scrub thoroughly for at least fifteen seconds.
Rinse completely and dry.

Inactive Ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance, Blue 1

1000 mL Bag Label

FOAMY BLUE
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-526
Route of Administration	TOPICAL

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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (dispensed as a light blue foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65585-526-01	800 mL in 1 BAG; Type 0: Not a Combination Product	01/18/2023	01/18/2023
2	NDC:65585-526-02	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/18/2023	01/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/18/2023	01/31/2025

Labeler - Whisk Products, Inc. (834270639)

Name	Address	ID/FEI	Business Operations
Establishment
Whisk Products, Inc.		834270639	manufacture(65585-526)