ALPHA E-2- 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 2.5%

Purpose

Skin Sanitizer

Use

reduces amount of bacteria on hands

Warnings

Avoid contact with eyes. If contents come in contact with eyes, flush with water for at least 15 minutes and get medical attention.

For external use only.

If irritation develops, use of this product should be discontinued. If irritation persists for more than 72 hours, consult a physician.

Do not allow concentrate to come in contact with food.

For institutional and professional use only.

Directions

Inactive Ingredients

Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, PEG-6 Cocamide, Hydroxypropyl Methylcellulose, Quaternium-15, Citric Acid, Sodium Hydroxide

Package Label - 1 gallon ShortNeck

ALPHA E-2 
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-495
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Color yellow (very pale yellow - very pale gold) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65585-495-01 3785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/21/2008
Labeler - Whisk Products, Inc. (834270639)
Establishment
Name Address ID/FEI Business Operations
Whisk Products, Inc. 834270639 manufacture(65585-495)

Revised: 1/2013
Document Id: 16d1c0ca-1266-4949-8b6d-c28a189813ab
Set id: 3e6d1589-7b71-4fa7-ad18-ec31d20ebc18
Version: 2
Effective Time: 20130131
 
Whisk Products, Inc.