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

  • Hands need not be washed prior to using.
  • Dispense a small amount into palm of hand.
  • Wash for at least 15 seconds.
  • Rinse with potable water.
  • Repeat as needed.

Inactive Ingredients

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

Label for ShortNeck Bottle - 1 gallon

ALPHA E-2 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-495
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (very pale yellow - very pale gold) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65585-495-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/21/200805/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/21/200805/04/2018
Labeler - Whisk Products, Inc. (834270639)
Establishment
NameAddressID/FEIBusiness Operations
Whisk Products, Inc.834270639manufacture(65585-495)

Revised: 5/2018
Document Id: 8a3e9eb8-db2a-4fd2-bedb-c040b64601a2
Set id: 3e6d1589-7b71-4fa7-ad18-ec31d20ebc18
Version: 4
Effective Time: 20180504
 
Whisk Products, Inc.