FDA.reportPublic FDA data

LOLES

Manufacturer
Diora Kimya Sanayi ve Ticaret Limited Sirketi | US Naturals Corp
Effective date
2022-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:58

Label at a glance#

ProductLOLES
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Antibacterial Bar Soap for Personal Use

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride........0.10%

OTC - PURPOSE SECTION

Antimicrobial. Antibacterial Bar Soap.

INDICATIONS & USAGE SECTION

  • For washing to decrease bacteria on the skin
  • Recommended for repeated use

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. If contact occurs, rinse thorougly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash appears and lasts.

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

  • Wet bar with water, wash skin and rinse

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Palm Kernelate, Aqua (Water), Fragrance (Parfum), Glycerin, Palm Acid, Sodium Chloride, Tetrasodium EDTA, Tetrasodium Etidronate, Avena Sativa (Oat) Kernel Flour, Tocopheryl Acetate (Vitamin E)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AVENAAVENA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSN3
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCD3
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73485-004-012024-01-30C16284748780-1d6a99b39-db56-a426-e053-dadaa90af4c2a72e4e4a-1e00-3d35-e053-2a95a90a64cc
73485-002-012022-01-31C16284748780-1d6a99b39-db56-a426-e053-dadaa90af4c2a72e4e4a-1e00-3d35-e053-2a95a90a64cc
73485-002-022022-01-31C16284748780-1d6a99b39-db56-a426-e053-dadaa90af4c2a72e4e4a-1e00-3d35-e053-2a95a90a64cc
73485-002-012022-01-28C16284748780-1d6a99b39-db56-a426-e053-dadaa90af4c2a72e4e4a-1e00-3d35-e053-2a95a90a64cc
73485-002-022022-01-28C16284748780-1d6a99b39-db56-a426-e053-dadaa90af4c2a72e4e4a-1e00-3d35-e053-2a95a90a64cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73485-004-01LOLES200 g in 1 BOXSOAP2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73485-004LOLES (BENZALKONIUM CHLORIDE) SOAP [DIORA KIMYA SANAYI VE TICARET LIMITED SIRKETI]3Legacy NDC, 1 package rows20221202_a72e4e4a-1e00-3d35-e053-2a95a90a64cc.zip

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
73485-00473485-004-01

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
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM PALMATES0A6004K3ZIACT
WATER059QF0KO0RIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
GLYCERINPDC6A3C0OXIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM CHLORIDE451W47IQ8XIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FRAGRANCE 135765EM498GW35IACT
PALM ACIDB6G0Y5Z616IACT
AVENA SATIVA LEAF206PI19V7RIACT

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
eec6bcf5-1b72-9971-e053-2995a90a0b43a72e4e4a-1e00-3d35-e053-2a95a90a64cc2022-12-01WarningsExact identifier
spl id: eec6bcf5-1b72-9971-e053-2995a90a0b43
spl set id: a72e4e4a-1e00-3d35-e053-2a95a90a64cc

Reported adverse events (FAERS/openFDA)#

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