FDA.reportPublic FDA data

Panrosa Antibacterial Hand Green Milk and Honey

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 23:24:42

Label at a glance#

ProductPanrosa Antibacterial Hand Green Milk and Honey
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, FD&C Yellow NO. 5, FD&C Red No.4.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-017-502023-01-30C16284748780-1f386c649-b29e-0266-e053-dadaa90a7c1aPanrosa Antibacterial Hand Soap - Milk and Honey

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-017-50Panrosa Antibacterial Hand Green Milk and Honey500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-017PANROSA ANTIBACTERIAL HAND GREEN MILK AND HONEY (CHLOROXYLENOL) GEL [PANROSA ENTERPRISES, INC.]1Legacy NDC, 1 package rows20200814_be55b085-6dfb-4592-ba3e-ceccd5d26920.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
50302-01750302-017-50

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
FD&C YELLOW NO. 5I753WB2F1MIACT
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
acc3cd87-198b-59a0-e053-2a95a90a69afbe55b085-6dfb-4592-ba3e-ceccd5d269202020-08-13WarningsExact identifier
spl id: acc3cd87-198b-59a0-e053-2a95a90a69af
spl set id: be55b085-6dfb-4592-ba3e-ceccd5d26920

Reported adverse events (FAERS/openFDA)#

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