Perineze Triple Dye
FDA Label NDC 55739-1022

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peace Medical Inc. for the product Perineze Triple Dye (NDC 55739-1022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each dose), purpose, use, contraindications, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Dose)

Brilliant green 2.29 mg

Proflavine hemisulfate 1.14 mg

gentian violet 2.29 mg

Purpose

Prevent Infection

Use

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

Contraindications

none

Warnings

for external use only

Otc - Keep Out Of Reach Of Children

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 15-30oC (58-86oF)

Inactive Ingredients

aqueous solution

Perineze Triple Dye Package Label

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.

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