FDA.reportPublic FDA data

Antibacterial

Manufacturer
The Right Solutions Corporation
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:01

Label at a glance#

ProductAntibacterial Utra 2x
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

WARNINGS SECTION

Warning For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

OTC - WHEN USING SECTION

When using the product

  • Do not get into eyes. If contact occurs rinse eye thoroughly with water

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 right away

DOSAGE & ADMINISTRATION SECTION

Direction

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

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow #5 (Cl 19140), Red #4 (Cl 14700)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64855-006-502022-05-18C16284748780-1d6a99b39-e306-a426-e053-dadaa90af4c2Spa Soap Ultra 2X Liquld Soap
64855-006-502022-01-28C16284748780-1d6a99b39-e306-a426-e053-dadaa90af4c2Spa Soap Ultra 2X Liquld Soap

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64855-00664855-006-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT

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
3d6cc4f1-a7ec-4f1e-9909-db72ef7718c2b07617f5-59de-107a-e053-2a95a90a1cb72022-05-18WarningsExact identifier
spl id: 3d6cc4f1-a7ec-4f1e-9909-db72ef7718c2
spl set id: b07617f5-59de-107a-e053-2a95a90a1cb7

Reported adverse events (FAERS/openFDA)#

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