ALPHA FOAMING 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.

----------

Active Ingredient

Benzethonium Chloride 1.255

Purpose

Skin Sanitizer

Use

sanitizes hands

Warnings

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

image description

ALPHA FOAMING E-2 
benzethonium chloride soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65585-490
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM12.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMINE OXIDE 
UNDECETH-7 
HYDROXYPROPYL METHYLCELLULOSE E5 [II] 
DMDM HYDANTOIN 
SODIUM HYDROXIDE 
CITRIC ACID MONOHYDRATE 
IODOPROPYNYL BUTYLCARBAMATE 
Product Characteristics
Colorwhite (water-white, dispensed as a white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65585-490-014 in 1 BOX
11000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/29/200711/30/2013
Labeler - Whisk Products, Inc. (834270639)
Establishment
NameAddressID/FEIBusiness Operations
Whisk Products, Inc.834270639manufacture(65585-490)

Revised: 10/2012
Document Id: b5926ecc-73b8-42f3-a814-c014dbc537bb
Set id: 334eb38f-1d73-406c-86c0-19c9759f51fa
Version: 1
Effective Time: 20121024
 
Whisk Products, Inc.