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

  • 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 15 seconds.
  • Rinse with potable water.

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 Description
1NDC:65585-510-014 in 1 BOX
11000 mL in 1 BAG
2NDC:65585-510-028 in 1 BOX
21000 mL in 1 BAG
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/FEIBusiness Operations
Whisk Products, Inc.834270639manufacture(65585-510)

Revised: 10/2012
Document Id: 144def5d-1abb-46c3-8af2-8cdf9f6a4078
Set id: bf4b0f6d-1c8d-4c60-bfdc-79999751f868
Version: 2
Effective Time: 20121025
 
Whisk Products, Inc.