FDA.reportPublic FDA data

Perineze Triple Dye

Manufacturer
Peace Medical Inc.
Effective date
2011-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:40

Label at a glance#

ProductPerineze Triple Dye
Active ingredientBRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET
Label structure9 sections

Dosage and administration

Peel paper portion of package down over base of ampule Avoid touching tip during removal With tip in downward position, pinch center to crush ampule. Apply to area to be prepped using accepted technique. Discard as non-hazardous waste.

Label contents#

Full prescribing information#

Active Ingredients (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Brilliant green 2.29 mg

Proflavine hemisulfate 1.14 mg

gentian violet 2.29 mg

Purpose

OTC - PURPOSE SECTION

Prevent Infection

Use

INDICATIONS & USAGE SECTION

aids in the prevention of infection in the umbilical cord area of newborn

Contraindications

CONTRAINDICATIONS SECTION

none

Warnings

WARNINGS SECTION

for external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

  • Peel paper portion of package down over base of ampule
  • Avoid touching tip during removal
  • With tip in downward position, pinch center to crush ampule.
  • Apply to area to be prepped using accepted technique.
  • Discard as non-hazardous waste.

Other information

SPL UNCLASSIFIED SECTION

store at controlled room temperature 15-30oC (58-86oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqueous solution

Perineze Triple Dye Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perineze® Triple Dye

UMBILICAL AREA ANTISEPTIC

Peace Medical, Inc.

CATALOG NUMBER 1022
250 UNIT DOSE AMPULES (.61 ML EACH)
NDC 55739-1022-3

Aids in prevention of infection in the umbilical area of the newborn.Perineze Triple Dye Outer boxPerineze Triple Dye Outer box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188515brilliant green 2.29 MG / proflavine 1.14 MG / gentian violet 2.29 MG in 0.61 mL Topical SolutionPSN1
1188520Perineze Triple Dye 2.29 MG / 1.14 MG / 2.29 MG in 0.61 mL Topical SolutionPSN1
1188520brilliant green 3.75 MG/ML / gentian violet 3.75 MG/ML / proflavine 1.87 MG/ML Topical Solution [Perineze Triple Dye]SBD1
1188515brilliant green 3.75 MG/ML / gentian violet 3.75 MG/ML / proflavine 1.87 MG/ML Topical SolutionSCD1
1188520Perineze Triple Dye (brilliant green 3.75 MG/ML / gentian violet 3.75 MG/ML / proflavine 1.87 MG/ML) Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55739-1022-32019-10-29C16284748780-1960f7f55-c3e6-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55739-1022-3Perineze Triple Dye250 in 1 BOXSOLUTION2501
55739-1022-3Perineze Triple Dye0.61 mL in 1 AMPULESOLUTION0.611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55739-1022PERINEZE TRIPLE DYE (BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET) SOLUTION [PEACE MEDICAL INC.]1Legacy NDC, 2 package rows20110929_074d2603-ec76-49ca-a0ae-79ce8b90d8ab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BRILLIANT GREENACTIVE INGREDIENTG0L543D3701
GENTIAN VIOLETACTIVE INGREDIENTJ4Z741D6O51
PROFLAVINE HEMISULFATEACTIVE INGREDIENT27V8M747VB1
BRILLIANT GREENACTIVE MOIETYG0L543D3701
GENTIAN VIOLETACTIVE MOIETYJ4Z741D6O51
PROFLAVINE HEMISULFATEACTIVE MOIETY27V8M747VB1
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
55739-102255739-1022-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRILLIANT GREENG0L543D370ACTIB
PROFLAVINE HEMISULFATE27V8M747VBACTIB
GENTIAN VIOLETJ4Z741D6O5ACTIB
WATER059QF0KO0RIACT

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
4e7ff19e-48ee-4d46-9b5f-c7ecd303d178074d2603-ec76-49ca-a0ae-79ce8b90d8ab2011-09-28WarningsExact identifier
spl id: 4e7ff19e-48ee-4d46-9b5f-c7ecd303d178
spl set id: 074d2603-ec76-49ca-a0ae-79ce8b90d8ab

Reported adverse events (FAERS/openFDA)#

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