ONE STEP ANTISEPTIC HAND WASH- benzalkonium chloride soap 
RECO Research Chemical Specialties Company, 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.

----------

One Step Antispetic Hand Wash 6265 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Benzalkonium Chloride 2.5%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

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

Drug Facts Box OTC-Inactive Ingredient Section

ater, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide,

PEG-75 lanolin, citric acid, FD and C red no.4

One Step Antispetic Hand Wash 6265 Drug Facts and Label

product label

One Step Antispetic Hand Wash 6265 Drug Facts and Label

ONE STEP ANTISEPTIC HAND WASH 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62830-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62830-265-5520820 mL in 1 DRUM; Type 0: Not a Combination Product12/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/27/2017
Labeler - RECO Research Chemical Specialties Company, Inc. (622536506)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62830-265)

Revised: 7/2019
Document Id: a3bcd8e3-2e5c-4098-a5d2-88ac644dd18c
Set id: 8378a0d4-6f05-42c9-aa58-35ec8eb88bf7
Version: 3
Effective Time: 20190709
 
RECO Research Chemical Specialties Company, Inc.