PERINEZE TRIPLE DYE- brilliant green, proflavine hemisulfate, gentian violet solution

Perineze Triple Dye by

Drug Labeling and Warnings

Perineze Triple Dye by is a Otc medication manufactured, distributed, or labeled by Peace Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

INGREDIENTS AND APPEARANCE

PERINEZE TRIPLE DYE 
brilliant green, proflavine hemisulfate, gentian violet solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55739-1022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRILLIANT GREEN (UNII: G0L543D370) (BRILLIANT GREEN - UNII:G0L543D370)	BRILLIANT GREEN	2.29 mg  in 0.61 mL
PROFLAVINE HEMISULFATE (UNII: 27V8M747VB) (PROFLAVINE HEMISULFATE - UNII:27V8M747VB)	PROFLAVINE HEMISULFATE	1.14 mg  in 0.61 mL
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET - UNII:J4Z741D6O5)	GENTIAN VIOLET	2.29 mg  in 0.61 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55739-1022-3	250 in 1 BOX
1		0.61 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/28/2011

Labeler - Peace Medical Inc. (010906881)

Establishment
Name	Address	ID/FEI	Business Operations
Peace Medical Inc.		010906881	manufacture