CLEAN HANDS INSTANT HAND SANITIZER- benzalkonium chloride liquid 
Atco International

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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Clean Hands Instant Hand Sanitizer Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

benzalkonium chloride USP 0.13%

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

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

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

Clean Hands Instant Hand Sanitizer

product label

Clean Hands Instant Hand Sanitizer

CLEAN HANDS INSTANT HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62712-457
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62712-457-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product10/04/2019
2NDC:62712-457-121000 mL in 1 BAG; Type 0: Not a Combination Product10/04/2019
3NDC:62712-457-13800 mL in 1 BAG; Type 0: Not a Combination Product10/04/2019
4NDC:62712-457-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/04/2019
5NDC:62712-457-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product10/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/04/2019
Labeler - Atco International (033504929)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62712-457)

Revised: 10/2019
Document Id: add37490-5aff-463e-b518-2744f241e942
Set id: faa2820f-506a-43c9-9a9b-5e1d524663de
Version: 1
Effective Time: 20191004
 
Atco International