ALPHA FOAMING 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 0.13%

Purpose

Antimicrobial

Uses

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

Inactive Ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid, fragrance

Case Label - 4 x 1000 mL


ALPHA FOAMING E-2 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65585-510
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCO GLUCOSIDE 
LAURTRIMONIUM CHLORIDE 
COCAMIDOPROPYLAMINE OXIDE 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Colorwhite (water-white, dispensed as a white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:65585-510-014 BAG in 1 BOXcontains a BAG
11000 mL in 1 BAGThis package is contained within the BOX (65585-510-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/22/2012

Labeler - Whisk Products, Inc. (834270639)
Establishment
NameAddressID/FEIOperations
Whisk Products, Inc.834270639manufacture

Revised: 10/2012 Whisk Products, Inc.