FDA.reportPublic FDA data

Antibacterial Hand Shea Butter Scented

Manufacturer
PANROSA ENTERPRISES, INC.
Effective date
2021-10-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:44:21

Label at a glance#

ProductAntibacterial Hand Shea Butter Scented
Active ingredientCHLOROXYLENOL
Label structure6 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

pump into hands, wet as needed lather vigorously for at leat 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 handwashing 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 leat 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

shea_soapshea_soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435989chloroxylenol 0.25 % Medicated Liquid SoapPSN6
1435989chloroxylenol 2.5 MG/ML Medicated Liquid SoapSCD6
1435989chloroxylenol 0.25 % Medicated Liquid SoapSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50302-520-002023-07-28C16284748780-19d75b9cf-f96b-f424-e053-dadaa90a57ceAntibacterial Hand Soap Shea Butter Scented
50302-520-002021-10-20C16284748780-19d75b9cf-f96b-f424-e053-dadaa90a57ceAntibacterial Hand Soap Shea Butter Scented
50302-520-002020-01-31C16284748780-19d75b9cf-f96b-f424-e053-dadaa90a57ceAntibacterial Hand Soap Shea Butter Scented

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50302-520-00Antibacterial Hand Shea Butter Scented500 mL in 1 BOTTLELIQUID5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50302-520ANTIBACTERIAL HAND SHEA BUTTER SCENTED (CHLOROXYLENOL) LIQUID [PANROSA ENTERPRISES, INC.]6Legacy NDC, 1 package rows20211021_61b13236-9669-4f0f-9577-0d1df4e93fb5.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50302-52050302-520-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 DISODIUM7FLD91C86KIACT
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
cece7e0d-0ac6-2c0f-e053-2995a90a37cf61b13236-9669-4f0f-9577-0d1df4e93fb52021-10-20WarningsExact identifier
spl id: cece7e0d-0ac6-2c0f-e053-2995a90a37cf
spl set id: 61b13236-9669-4f0f-9577-0d1df4e93fb5

Reported adverse events (FAERS/openFDA)#

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