FDA.reportPublic FDA data

Moonlite Antibacterial

Manufacturer
Brands International Corporation
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:30:01

Label at a glance#

ProductMoonlite Antibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antiseptique(skin)cleanser

INDICATIONS & USAGE SECTION

Uses Effective in destorying(harmful) bacteria to provide antiseptic cleansing.

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

  • avoid contact wiith 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

  • Adults and children over 2 year
  • For occasional and personal domestic use
  • Supervise children when use this product
  • Lather in hands with water for at least 30 seconds 
  • Rinse well

OTHER SAFETY INFORMATION

  • Store below 110F(43)
  • May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT SECTION

Water,Lauramidopropylamine Oxide ( Triaminox LO ), Lauryl Glucoside, Citric Acid, PEG-150 distearate, Glycol Stearate, PEG-7 Glyceryl Cocoate,Cetrimonium Chloride, Tetrasodium EDTA,Isopropyl myristate, Aloe Leaf, Tocopheryl Acetate, Methylchloroisothiazolinone, Methylisothiazolinone,

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
50157-511-232025-01-30C16284748780-12cef2736-5b27-d83d-e063-dadaa90ab31fMoon Lite Antibacterial Soap: Sulfate-Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-511-23Moonlite Antibacterial236 mL in 1 BOTTLE, PLASTICLIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-511MOONLITE ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 1 package rows20200924_9fce89e5-812f-405e-a42a-3bda4cf4030d.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-51150157-511-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
GLYCOL STEARATE0324G66D0EIACT
WATER059QF0KO0RIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
EDETATE SODIUMMP1J8420LUIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
b0000e40-a63a-9263-e053-2a95a90a2f5f9fce89e5-812f-405e-a42a-3bda4cf4030d2020-09-23WarningsExact identifier
spl id: b0000e40-a63a-9263-e053-2a95a90a2f5f
spl set id: 9fce89e5-812f-405e-a42a-3bda4cf4030d

Reported adverse events (FAERS/openFDA)#

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