FDA.reportPublic FDA data

Antibacterial Moisturizing

Manufacturer
Brands International Corporation
Effective date
2021-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:27

Label at a glance#

ProductAntibacterial Moisturizing Rosemary Mint Aloe and Vitamin E
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antiseptic Skin cleanser

INDICATIONS & USAGE SECTION

Effective in destroying (harmful) bacteria to provide antiseptic cleansing

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

  • avoid contact with 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:

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

INACTIVE INGREDIENT SECTION

Lauramidopropylamine oxide, Lauryl Glucoside, PEG-150 distearate, Glycol Stearate, Perfume, PEG-7 glycerly cocoate, Cetrimonium Chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Isopropyl myristate, Tocopheryl Acetate.

Yellow 6,Blue 1.

OTHER SAFETY INFORMATION

  • Store below 59F-86F
  • May discolor certain fabrics or surfaces.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55667788

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
50157-515-102025-01-30C16284748780-12cef2736-785d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap - Rosemary Mint
50157-515-232025-01-30C16284748780-12cef2736-785d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap - Rosemary Mint
50157-515-372025-01-30C16284748780-12cef2736-785d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap - Rosemary Mint
50157-515-442025-01-30C16284748780-12cef2736-785d-d83d-e063-dadaa90ab31fGerms be Gone Antibacterial Hand Soap - Rosemary Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-515-10Antibacterial MoisturizingRosemary Mint Aloe and Vitamin E1000 mL in 1 BOTTLE, PLASTICLIQUID10002
50157-515-23Antibacterial MoisturizingRosemary Mint Aloe and Vitamin E236 mL in 1 BOTTLE, PLASTICLIQUID2362
50157-515-37Antibacterial MoisturizingRosemary Mint Aloe and Vitamin E3780 mL in 1 BOTTLE, PLASTICLIQUID37802
50157-515-44Antibacterial MoisturizingRosemary Mint Aloe and Vitamin E443 mL in 1 BOTTLE, PLASTICLIQUID4432

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-515ANTIBACTERIAL MOISTURIZING ROSEMARY MINT ALOE AND VITAMIN E (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 4 package rows20210128_94e0b598-7a87-482a-acfa-cc4f3b5b7f07.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-51550157-515-37, 50157-515-10, 50157-515-23, 50157-515-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCOL STEARATE0324G66D0EIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b9e49af0-a6fe-1ac7-e053-2995a90a541194e0b598-7a87-482a-acfa-cc4f3b5b7f072021-01-27WarningsExact identifier
spl id: b9e49af0-a6fe-1ac7-e053-2995a90a5411
spl set id: 94e0b598-7a87-482a-acfa-cc4f3b5b7f07

Reported adverse events (FAERS/openFDA)#

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