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Perineze Triple Dye

Dosage form: solution
Ingredients: BRILLIANT GREEN 2.29mg in 0.61mL, PROFLAVINE HEMISULFATE 1.14mg in 0.61mL, GENTIAN VIOLET 2.29mg in 0.61mL
Labeler: Peace Medical Inc.
NDC Code: 55739-1022

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)

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 
brilliant green, proflavine hemisulfate, gentian violet solution
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:55739-1022-3250 AMPULE (AMPULE) 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/FEIOperations
Peace Medical Inc.010906881manufacture

Revised: 09/2011
Document Id: 4e7ff19e-48ee-4d46-9b5f-c7ecd303d178
Set id: 074d2603-ec76-49ca-a0ae-79ce8b90d8ab
Version: 1
Effective Time: 20110928
 
Peace Medical Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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