HAND-GIENE E-2 - benzethonium 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
Benzethonium Chloride 1.25% w/w

Purpose
Skin Sanitizer

Use
Sanitizes hands

Warnings
Avoid contact with eyes. If contents come in contact with eyes, flush eyes with water for at least 15 minutes and get medical attention.
Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a physician.
For institutional and professional use only.

KEEP OUT OF REACH OF CHILDREN.

Directions

Hands need not be washed prior to using.
Enough foam should be dispensed to cover hands.
Scrub thoroughly for at least 15 seconds with potable water.
Repeat as needed.

Inactive Ingredients
Water, Cocamine Oxide, Hydrogenated Starch Hydrolysate, Undeceth-7, Hydroxypropyl Methylcellulose, DMDM Hydantoin, Sodium Hydroxide, Citric Acid, Iodopropynyl Butylcarbamate

Case Label - 1000 mL x 4

HAND-GIENE E-2
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-496
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (BENZETHONIUM)	BENZETHONIUM CHLORIDE	12.5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
COCAMINE OXIDE
UNDECETH-7
HYPROMELLOSES
DMDM HYDANTOIN
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE
IODOPROPYNYL BUTYLCARBAMATE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:65585-496-01	4 BAG in 1 BOX	contains a BAG
1		1000 mL in 1 BAG	This package is contained within the BOX (65585-496-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/12/2008	11/06/2012

Labeler - Whisk Products, Inc. (834270639)

Establishment
Name	Address	ID/FEI	Operations
Whisk Products, Inc.		834270639	manufacture

Revised: 11/2012 Whisk Products, Inc.