KERR 100 TRIPLE DYE DISPOS-A (PROFLAVINE HEMISULFATE, BRILLIANT GREEN, AND GENTIAN VIOLET) SWAB [VISTAPHARM, INC.]

KERR 100 TRIPLE DYE DISPOS-A (PROFLAVINE HEMISULFATE, BRILLIANT GREEN, AND GENTIAN VIOLET) SWAB [VISTAPHARM, INC.]
PDF | XML

NDC 66689-710-06
Set ID 44e0306a-2c14-4cc3-9ac1-218c0c8b15a0
Category HUMAN OTC DRUG LABEL
Packager VistaPharm, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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)