SAFE HANDS U-357- benzalkonium chloride soap
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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Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand washing to decrease bacteria on the skin
Recommended for repeated use

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

Pump a small amount of foam into palm of hand.
Rub thoroughly over all surfaces of both hands for fifteen seconds.
Rinse with potable water.

Inactive Ingredients

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid

Case Label M-4

SAFE HANDS U-357
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-512
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65585-512-01	4 in 1 BOX	06/26/2013	04/26/2019
1		4000 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 not final	part333E	06/26/2013	04/26/2019

Labeler - Whisk Products, Inc. (834270639)

Name	Address	ID/FEI	Business Operations
Establishment
Whisk Products, Inc.		834270639	manufacture(65585-512)

Revised: 4/2019

Document Id: c0058791-b0c5-4384-8321-a7dd7355be5e

Set id: 72170827-cbec-401a-9fb9-c549024878fc

Version: 2

Effective Time: 20190426

Whisk Products, Inc.