QS PLUS HAND SANITIZING WIPES - benzethonium chloride cloth 
Romaine Companies

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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QS Plus Hand Sanitizing Wipes 7805 Drug Facts and Label

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

QS Plus Hand Sanitizing Wipes 7805 50 pre-moistened wipes

780550Q3955.jpg   QS Plus Hand Sanitizing Wipes  50 pre-moistened wipesimage of canister label

QS PLUS HAND SANITIZING WIPES 
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13302-785
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13302-785-23302 g in 1 CANISTER
2NDC:13302-785-29617 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33310/01/2009
Labeler - Romaine Companies (929229797)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 3/2010
Document Id: e5da40f4-994c-4389-b39d-6fc04ca15bf1
Set id: 8c93495e-7b7f-4971-a80a-23c6c2a7b9fa
Version: 1
Effective Time: 20100316
 
Romaine Companies