FDA.reportPublic FDA data

Panrosa Antibacterial Hand Rose

Manufacturer
Panrosa Enterprises, Inc.
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:38

Label at a glance#

ProductPanrosa Antibacterial Hand Rose
Active ingredientCHLOROXYLENOL
Label structure6 sections

Indications and uses

for hand washing to decrease bacteria on the skin

Dosage and administration

pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse and dry thoroughly

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.25%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • for hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develops.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pump into hands, wet as needed
  • lather vigorously for at least 15 seconds
  • wash skin, rinse and dry thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Glycerin, Glycol Stearate, Sodium Chloride, PEG-150 Distearate, Citric Acid, Fragrance, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, D&C Red NO. 33 FD&C Red No.4.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435989chloroxylenol 0.25 % Medicated Liquid SoapPSN1
1435989chloroxylenol 2.5 MG/ML Medicated Liquid SoapSCD1
1435989chloroxylenol 0.25 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-016-502023-01-30C16284748780-1f386c64a-42b1-0266-e053-dadaa90a7c1aPanrosa Antibacterial Hand Soap - Rose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-016-50Panrosa Antibacterial Hand Rose500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-016PANROSA ANTIBACTERIAL HAND ROSE (CHLOROXYLENOL) GEL [PANROSA ENTERPRISES, INC.]1Legacy NDC, 1 package rows20200814_11b94d98-2de9-4bcf-9b52-6b2381f573df.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
50302-01650302-016-50

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
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERINPDC6A3C0OXIACT
GLYCOL STEARATE0324G66D0EIACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 4X3W0AM1JLXIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
acc3c1a2-e246-1ec4-e053-2995a90aa87b11b94d98-2de9-4bcf-9b52-6b2381f573df2020-08-13WarningsExact identifier
spl id: acc3c1a2-e246-1ec4-e053-2995a90aa87b
spl set id: 11b94d98-2de9-4bcf-9b52-6b2381f573df

Reported adverse events (FAERS/openFDA)#

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