Label: KERR 100 TRIPLE DYE DISPOS-A- proflavine hemisulfate, brilliant green, and gentian violet swab

  • 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 October 1, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each dose)Purpose
     Brilliant green 2.29 mg Prevent Infection
     Proflavine hemisulfate 1.14 mg Prevent Infection
     Gentian violet 2.29 mg 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° - 30° C (58° - 86° F)

  • Inactive ingredients

    aqueous solution

  • PRINCIPAL DISPLAY PANEL - 100 Swab Box

    VistaPharm®

    100 TRIPLE DYE DISPOS•A•SWABS

    UMBILICAL AREA ANTISEPTIC

    Each Dispos-A-Swab contains
    0.65ml. Each ml contains brilliant
    green 2.29mg, gentian violet
    2.29mg, proflavine hemisulfate
    1.14mg, in an aqueous solution.

    KERR TRIPLE DYE

    PACKAGED BY: VistaPharm, Inc., Largo, FL 33771, USA

    Carton-Label
  • INGREDIENTS AND APPEARANCE
    KERR 100 TRIPLE DYE DISPOS-A 
    proflavine hemisulfate, brilliant green, and gentian violet swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66689-710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROFLAVINE HEMISULFATE (UNII: 27V8M747VB) (PROFLAVINE - UNII:CY3RNB3K4T) PROFLAVINE HEMISULFATE1.14 mg  in 1 mL
    BRILLIANT GREEN (UNII: G0L543D370) (BRILLIANT GREEN CATION - UNII:S85JD8CLBH) BRILLIANT GREEN2.29 mg  in 1 mL
    GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET2.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREEN (Violet) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66689-710-06100 in 1 BOX05/01/2004
    11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/01/2004
    Labeler - VistaPharm, Inc. (116743084)