Kerr 100 Triple Dye Dispos-A: Package Insert and Label Information

KERR 100 TRIPLE DYE DISPOS-A- proflavine hemisulfate, brilliant green and gentian violet swab
VistaPharm, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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

Contraindications

none

Warnings

for external use only.

Keep out of reach of children.

Directions

  • 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

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

Inactive ingredients

aqueous solution

PRINCIPAL DISPLAY PANEL — 100 Swab Box

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
(click image for full-size original)
KERR 100 TRIPLE DYE DISPOS-A
proflavine hemisulfate, brilliant green, and gentian violet swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-710
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROFLAVINE HEMISULFATE (PROFLAVINE) PROFLAVINE HEMISULFATE 1.14 mg in 1 mL
BRILLIANT GREEN (BRILLIANT GREEN CATION) BRILLIANT GREEN 2.29 mg in 1 mL
GENTIAN VIOLET (GENTIAN VIOLET CATION) GENTIAN VIOLET 2.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color green (Violet) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66689-710-06 100 APPLICATOR in 1 BOX contains a APPLICATOR
1 1 mL in 1 APPLICATOR This package is contained within the BOX (66689-710-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/01/2004
Labeler — VistaPharm, LLC (116743084)

Revised: 11/2022 VistaPharm, LLC

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