FDA.reportPublic FDA data

BENZALKONIUM CHLORIDE

Manufacturer
Panrosa Enterprises, Inc.
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:54

Label at a glance#

ProductPANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

hand sanitizer to help decrease bacteria on the skin, when water, soap & towel are not available. recommended for repeated use.

Dosage and administration

pump as needed into your palms and thoroughly spread on both hands. rub into skin until dry.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to help decrease bacteria on the skin, when water, soap & towel are not available.
  • recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use

OTC - DO NOT USE SECTION

in ears & mouth.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pump as needed into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

SPL UNCLASSIFIED SECTION

  • store at 20°C (68°F to 77°F).
  • may discolor fabrics. 

Inactive ingredinets

INACTIVE INGREDIENT SECTION

WATER, HYDROXYETHYLCELLULOSE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, FRAGRANCE, ALOE BARBADENSIS JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

Package Labeling:50302-12-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:50302-12-23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling: 118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN2
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD2
1098199benzalkonium chloride 0.13 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-012-182023-01-30C16284748780-1f386c64a-2e43-0266-e053-dadaa90a7c1aPANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers
50302-012-232023-01-30C16284748780-1f386c64a-2e43-0266-e053-dadaa90a7c1aPANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers
50302-012-502023-01-30C16284748780-1f386c64a-2e43-0266-e053-dadaa90a7c1aPANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers
50302-012-592023-01-30C16284748780-1f386c64a-2e43-0266-e053-dadaa90a7c1aPANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-012-18PANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers118 mL in 1 TUBEGEL1182
50302-012-23PANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers237 mL in 1 BOTTLEGEL2372
50302-012-50PANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers500 mL in 1 BOTTLEGEL5002
50302-012-59PANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers59 mL in 1 TUBEGEL592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-012PANROSA ALCOHOL-FREE HAND SANITIZER WITH REFRESHING ALOE DUAL ACTION MOISTURIZERS (BENZALKONIUM CHLORIDE) GEL [PANROSA ENTERPRISES, INC.]2Legacy NDC, 4 package rows20200703_4ca29b1f-085f-40bb-905d-ae95ceead6bc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50302-01250302-012-50, 50302-012-23, 50302-012-59, 50302-012-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
a977b412-4df4-2b8d-e053-2a95a90a887c4ca29b1f-085f-40bb-905d-ae95ceead6bc2020-07-02WarningsExact identifier
spl id: a977b412-4df4-2b8d-e053-2a95a90a887c
spl set id: 4ca29b1f-085f-40bb-905d-ae95ceead6bc

Reported adverse events (FAERS/openFDA)#

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