FDA.reportPublic FDA data

PLUS BRASEPT THD

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 21:34:04

Label at a glance#

ProductPLUS BRASEPT THD
Active ingredientCHLOROXYLENOL
Label structure10 sections

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

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, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

PLUS BRASEPT THD

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

plus brasept thd labelplus brasept thd label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83318-544-412025-02-01C16284748780-12cef2736-65cf-d83d-e063-dadaa90ab31fPLUS BRASEPT THD 6544 Drug Facts and Label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83318-54483318-544-41

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
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
SODIUM CHLORIDE451W47IQ8XIACT
DMDM HYDANTOINBYR0546TOWIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
2d04778c-ec43-6a61-e063-6294a90ae449f7927bf2-a2ed-8006-e053-6394a90ad0252025-01-31WarningsExact identifier
spl set id: f7927bf2-a2ed-8006-e053-6394a90ad025

Reported adverse events (FAERS/openFDA)#

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