PLUS BRASEPT 6265 Drug Facts and Label

PLUS BRASEPT by

Drug Labeling and Warnings

PLUS BRASEPT by is a Otc medication manufactured, distributed, or labeled by NEWDROP NORTH AMERICA LLC, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLUS BRASEPT- benzalkonium chloride soap 
NEWDROP NORTH AMERICA LLC

----------

PLUS BRASEPT 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

  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

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

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

PLUS BRASEPT 6265

PLUS BRASEPT LABEL

PLUS BRASEPT 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83318-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25 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: 83318-265-413785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/202301/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00403/23/202301/31/2025
Labeler - NEWDROP NORTH AMERICA LLC (094392481)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(83318-265)

Revised: 1/2025
Document Id: 2d046181-2a64-6980-e063-6394a90ae686
Set id: f793cdb3-9fc6-79e1-e053-6394a90ae08b
Version: 2
Effective Time: 20250131