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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

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  • Active Ingredients (in each dose)

    Brilliant green 2.29 mg

    Proflavine hemisulfate 1.14 mg

    gentian violet 2.29 mg

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  • Purpose

    Prevent Infection

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  • Use

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

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  • Contraindications

    none

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  • Warnings

    for external use only

    KEEP OUT OF REACH OF CHILDREN

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  • 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.
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  • Other information

    store at controlled room temperature 15-30oC (58-86oF)

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  • Inactive ingredients

    aqueous solution

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  • 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

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  • INGREDIENTS AND APPEARANCE
    PERINEZE TRIPLE DYE 
    brilliant green, proflavine hemisulfate, gentian violet solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55739-1022
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BRILLIANT GREEN (BRILLIANT GREEN) BRILLIANT GREEN 2.29 mg  in 0.61 mL
    PROFLAVINE HEMISULFATE (PROFLAVINE HEMISULFATE) PROFLAVINE HEMISULFATE 1.14 mg  in 0.61 mL
    GENTIAN VIOLET (GENTIAN VIOLET) GENTIAN VIOLET 2.29 mg  in 0.61 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    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
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