FDA.reportPublic FDA data

Kerr 100 Triple Dye Dispos-A

Manufacturer
VistaPharm, LLC
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:20:23

Label at a glance#

ProductKerr 100 Triple Dye Dispos-A
Active ingredientPROFLAVINE HEMISULFATE, BRILLIANT GREEN, 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.

Storage and handling

store at controlled room temperature 15° - 30° C (58° - 86° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each dose)Purpose
 Brilliant green 2.29 mg Prevent Infection
 Proflavine hemisulfate 1.14 mg Prevent Infection
 Gentian violet 2.29 mg 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

STORAGE AND HANDLING SECTION

store at controlled room temperature 15° - 30° C (58° - 86° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqueous solution

PRINCIPAL DISPLAY PANEL - 100 Swab Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VistaPharm®

100 TRIPLE DYE DISPOS•A•SWABS

UMBILICAL AREA ANTISEPTIC

Each Dispos-A-Swab contains
0.65ml. Each ml contains brilliant
green 2.29mg, gentian violet
2.29mg, proflavine hemisulfate
1.14mg, in an aqueous solution.

KERR TRIPLE DYE

PACKAGED BY: VistaPharm, Inc., Largo, FL 33771, USA

Carton-Label
Carton-Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-710KERR 100 TRIPLE DYE DISPOS-A (PROFLAVINE HEMISULFATE, BRILLIANT GREEN, AND GENTIAN VIOLET) SWAB [VISTAPHARM, LLC]5Legacy NDC20231121_44e0306a-2c14-4cc3-9ac1-218c0c8b15a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-710-06EA - Each66689-7104adc1968-c3e8-4233-8401-8dbe4c7acc8212016-11-08

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66689-71066689-710-06

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
PROFLAVINE HEMISULFATE27V8M747VBACTIB
BRILLIANT GREENG0L543D370ACTIB
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
560f4b24-6b67-48c7-b086-9d877ab4451e44e0306a-2c14-4cc3-9ac1-218c0c8b15a02026-02-02WarningsExact identifier
spl set id: 44e0306a-2c14-4cc3-9ac1-218c0c8b15a0

Reported adverse events (FAERS/openFDA)#

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