FDA.reportPublic FDA data

Castellani Paint

Manufacturer
Stratus Pharamceuticals | TARMAC PRODUCTS INC
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:24

Label at a glance#

ProductCastellani Paint
Active ingredientPhenol
Label structure11 sections

Indications and uses

First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Dosage and administration

clean the affected area apply a small amount on the area one to three times daily.

Storage and handling

Store at controlled room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.5%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes
  • with bandages
  • on large areas of the body longer than one week unless directed by a doctor
  • stop use and consult a doctor if condition persists
  • in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
  • if known to be sensitive to any ingredients in this product,

OTC - STOP USE SECTION

Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or the condition persists or gets worse.

When using this product

OTC - WHEN USING SECTION

  • check skin for sensitivity to phenol prior to application.
  • care should be taken to avoid spilling and guard against staining. Castellani Paint Modified will stain skin and clothing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount on the area one to three times daily.

Other Information

STORAGE AND HANDLING SECTION

Store at controlled room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acetone, Purified Water, Resorcinol, SD alcohol 40B (13%).

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-820-10

Castellani Paint

modified colorless phenol 1.5%

STRATUS
PHARMACEUTICALS INC

FIRST AID ANTISEPTIC

NET VOL. 1.0 FL OZ (29.57 mL)

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box
PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309033Castellani Paint 1.5 % Topical SolutionPSN3
199858phenol 1.5 % Topical SolutionPSN3
309033phenol 15 MG/ML Topical Solution [Castellani Paint]SBD3
199858phenol 15 MG/ML Topical SolutionSCD3
309033Castellani Paint 1.5 % Topical SolutionSY3
309033Castellani Paint 15 MG/ML Topical SolutionSY3
199858phenol 1.5 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-820-10Castellani Paint29.57 mL in 1 BOTTLELIQUID29.573
58980-820-10Castellani Paint1 in 1 BOXLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-820-10ML - Milliliter58980-82044ce42ec-4cd6-41ce-b1ab-30ab7b5f328f12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PhenolACTIVE INGREDIENT339NCG44TV1
PhenolACTIVE MOIETY339NCG44TV1
ACETONEINACTIVE INGREDIENT1364PS73AF1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
RESORCINOLINACTIVE INGREDIENTYUL4LO94HK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58980-82058980-820-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Phenol339NCG44TVACTIB
Water059QF0KO0RIACT
ACETONE1364PS73AFIACT
RESORCINOLYUL4LO94HKIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22017-10-19full-release2026-05-31 22:52:46

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
30 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
30 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
30 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
30 equally ranked IID candidates

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
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
ndc (package): 58980-820-10
ndc (product): 58980-820
ndc11 (package): 58980082010
spl id: 6e490b46-1794-4d44-95b6-9b4580833577
spl set id: 74192c0e-3c73-4ab0-96d1-1917cbd6777a

Reported adverse events (FAERS/openFDA)#

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