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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated September 28, 2011

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  • 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

  • INGREDIENTS AND APPEARANCE
    PERINEZE TRIPLE DYE 
    brilliant green, proflavine hemisulfate, gentian violet solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55739-1022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRILLIANT GREEN (UNII: G0L543D370) (BRILLIANT GREEN - UNII:G0L543D370) BRILLIANT GREEN2.29 mg  in 0.61 mL
    PROFLAVINE HEMISULFATE (UNII: 27V8M747VB) (PROFLAVINE HEMISULFATE - UNII:27V8M747VB) PROFLAVINE HEMISULFATE1.14 mg  in 0.61 mL
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET - UNII:J4Z741D6O5) GENTIAN VIOLET2.29 mg  in 0.61 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    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
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