SOAPY HANDS   - benzethonium chloride cloth 
Superior Chemical Corporation

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.

----------

Drug Facts Box OTC-Active Ingredient Section

benzethonium chloride USP 0.2%

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box-OTC When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box-OTC Stop Use Section

irritation and redness develop

Drug Facts Box-OTC Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box-OTC Dosage & Administration Section

wet hands thoroughly with product and allow to air dry without wiping
wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, fragrance

Soapy Hands 7805 50 pre-moistened wipes

780550P4060.jpg  Soapy Hands  50 pre-moistened wipes  image of canister label


SOAPY HANDS  
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-785
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DIMETHICONE 
IODOPROPYNYL BUTYLCARBAMATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:58575-785-23302 g in 1 CANISTERNone
2NDC:58575-785-29617 g in 1 CANISTERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/11/201108/10/2012

Labeler - Superior Chemical Corporation (023335086)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIOperations
ABC Compounding Co., Inc.003284353manufacture

Revised: 07/2011 Superior Chemical Corporation