FDA.reportPublic FDA data

Panrosa Alcohol Free Hand Sanitizer

Manufacturer
Panrosa Enterprises, Inc.
Effective date
2020-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:54

Label at a glance#

ProductPanrosa Alcohol Free Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 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 need 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 need 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 dscolor fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride, Lauramine Oxide, Cocamide Methyl MEA, Sodium Chloride, Propanediol, Parfum (Fragrance), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone.

Package Labeling: 50302-004-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 50302-004-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN1
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD1
1098199benzalkonium chloride 0.13 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-004-002023-01-30C16284748780-1f386c64a-2da7-0266-e053-dadaa90a7c1aPanrosa Alcohol Free Hand Sanitizer
50302-004-012023-01-30C16284748780-1f386c64a-2da7-0266-e053-dadaa90a7c1aPanrosa Alcohol Free Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-004-00Panrosa Alcohol Free Hand Sanitizer296 mL in 1 BOTTLEGEL2961
50302-004-01Panrosa Alcohol Free Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-004PANROSA ALCOHOL FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [PANROSA ENTERPRISES, INC.]1Legacy NDC, 2 package rows20200309_a035ba11-14e2-7710-e053-2995a90ae3ad.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50302-00450302-004-00, 50302-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCOYL METHYL MONOETHANOLAMINE79G1T427CFIACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
a035bcc0-4b48-be04-e053-2a95a90af813a035ba11-14e2-7710-e053-2995a90ae3ad2020-03-06WarningsExact identifier
spl id: a035bcc0-4b48-be04-e053-2a95a90af813
spl set id: a035ba11-14e2-7710-e053-2995a90ae3ad

Reported adverse events (FAERS/openFDA)#

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