FDA.reportPublic FDA data

PLUS BRASEPT

Manufacturer
NEWDROP NORTH AMERICA LLC | ABC Compounding Co., Inc.
Effective date
2023-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:34:05

Label at a glance#

ProductPLUS BRASEPT
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 2.5%

Drug Facts Box OTC-Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

INDICATIONS & USAGE SECTION

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

WARNINGS SECTION

For external use only

Drug Facts Box OTC-When Using Section

OTC - WHEN USING SECTION

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

OTC - STOP USE SECTION

irritation and redness develop

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

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

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLUS BRASEPT LABELPLUS BRASEPT LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83318-265-412025-02-01C16284748780-12cef2736-9a3e-d83d-e063-dadaa90ab31fPLUS BRASEPT 6265 Drug Facts and Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83318-26583318-265-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)L605B5892VIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
PEG-75 LANOLIN09179OX7TBIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 4X3W0AM1JLXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2d046181-2a64-6980-e063-6394a90ae686f793cdb3-9fc6-79e1-e053-6394a90ae08b2025-01-31WarningsExact identifier
spl set id: f793cdb3-9fc6-79e1-e053-6394a90ae08b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.