FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corporation
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:19

Label at a glance#

ProductAntibacterial Vanilla and Shea Butter
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antiseptic Skin cleanser

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

WARNINGS SECTION

Warnings 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 this product

  • do not get it 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

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse
  • For occasional and personal domestic use
  • Supervise children when they use this product.

INACTIVE INGREDIENT SECTION

Lauramidopropylamine oxide, lauryl glucoside, PEG-150 distearate, glycol stearate, perfume, PEG-7 glycerly cocoate, centrimonium chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone,

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

221133soap1soap1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-508-102025-01-30C16284748780-12cef2736-af0d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap: Vanilla and Shea Butter
50157-508-232025-01-30C16284748780-12cef2736-af0d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap: Vanilla and Shea Butter
50157-508-372025-01-30C16284748780-12cef2736-af0d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap: Vanilla and Shea Butter
50157-508-442025-01-30C16284748780-12cef2736-af0d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap: Vanilla and Shea Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-508-10AntibacterialVanilla and Shea Butter1000 mL in 1 BOTTLE, PLASTICLIQUID10002
50157-508-23AntibacterialVanilla and Shea Butter236 mL in 1 BOTTLE, PLASTICLIQUID2362
50157-508-37AntibacterialVanilla and Shea Butter3780 mL in 1 BOTTLE, PLASTICLIQUID37802
50157-508-44AntibacterialVanilla and Shea Butter443 mL in 1 BOTTLE, PLASTICLIQUID4432

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-508ANTIBACTERIAL VANILLA AND SHEA BUTTER (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 4 package rows20200915_aefd54bc-4707-d591-e053-2995a90a08ed.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-50850157-508-23, 50157-508-37, 50157-508-10, 50157-508-44

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
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCOL STEARATE0324G66D0EIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PEG-150 DISTEARATE6F36Q0I0ACIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT

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
af4bb6ee-7847-4d11-e053-2995a90a0520aefd54bc-4707-d591-e053-2995a90a08ed2020-09-14WarningsExact identifier
spl id: af4bb6ee-7847-4d11-e053-2995a90a0520
spl set id: aefd54bc-4707-d591-e053-2995a90a08ed

Reported adverse events (FAERS/openFDA)#

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