FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corp
Effective date
2016-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:44

Label at a glance#

ProductAntibacterial
Active ingredientTRICLOSAN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient - Triclosan 0.115%

OTC - PURPOSE SECTION

purpose - antibacterial

INDICATIONS & USAGE SECTION

Use for handwashing to decrease bacteria on skin

WARNINGS SECTION

Warning

for extrenal use only - hands only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor If irritation or redness develops and if condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Direction

  • Wet hands
  • apply to hands
  • scrub thoroughly
  • rinse thoroughly

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphacetate, Glycerin, Polyquaternium - 7, Citric Acid, Tocopheryl Acetate, (Vit E Acetate), Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (Cl 17200), Blue 1 (42090)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Visibly Clean Antibacterial Hand SoapVisibly Clean Antibacterial Hand Soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995367triclosan 0.115 % Medicated Liquid SoapPSN1
995367triclosan 1.15 MG/ML Medicated Liquid SoapSCD1
995367triclosan 0.115 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-202-252021-01-29C16284748780-1ba0f9c33-222e-a910-e053-dadaa90a0b853f90a5ae-8774-1312-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-202-25Antibacterial739 mL in 1 BOTTLELIQUID7391

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-202ANTIBACTERIAL (TRICLOSAN) LIQUID [BRANDS INTERNATIONAL CORP]1Legacy NDC, 1 package rows20161024_3f90a5ae-8774-1312-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-20250157-202-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM CHLORIDE451W47IQ8XIACT
TRICLOSAN4NM5039Y5XACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
3f90a5ae-8775-1312-e054-00144ff8d46c3f90a5ae-8774-1312-e054-00144ff8d46c2016-10-23WarningsExact identifier
spl id: 3f90a5ae-8775-1312-e054-00144ff8d46c
spl set id: 3f90a5ae-8774-1312-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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