Your browser does not support JavaScript! PERINEZE TRIPLE DYE (BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET) SOLUTION [PEACE MEDICAL INC.]
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RxNorm Names

PERINEZE TRIPLE DYE (brilliant green, proflavine hemisulfate, gentian violet) solution
[Peace Medical Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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.Perineze Triple Dye Outer box

PERINEZE TRIPLE DYE 
brilliant green, proflavine hemisulfate, gentian violet solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55739-1022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRILLIANT GREEN (BRILLIANT GREEN) BRILLIANT GREEN2.29 mg  in 0.61 mL
PROFLAVINE HEMISULFATE (PROFLAVINE HEMISULFATE) PROFLAVINE HEMISULFATE1.14 mg  in 0.61 mL
GENTIAN VIOLET (GENTIAN VIOLET) GENTIAN VIOLET2.29 mg  in 0.61 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55739-1022-3250 in 1 BOX
10.61 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/28/2011
Labeler - Peace Medical Inc. (010906881)
Establishment
NameAddressID/FEIBusiness Operations
Peace Medical Inc.010906881manufacture

Revised: 9/2011
 
Peace Medical Inc.

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