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 September 23, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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
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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° - 30° C (58° - 86° F)

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  • Inactive ingredients

    aqueous solution

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  • 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

    PRINCIPAL DISPLAY PANEL - 100 Swab Box
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  • INGREDIENTS AND APPEARANCE
    KERR 100 TRIPLE DYE DISPOS-A 
    proflavine hemisulfate, brilliant green, and gentian violet swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-710
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PROFLAVINE HEMISULFATE (UNII: 27V8M747VB) (PROFLAVINE - UNII:CY3RNB3K4T) PROFLAVINE HEMISULFATE 1.14 mg  in 1 mL
    Brilliant Green (UNII: G0L543D370) (BRILLIANT GREEN CATION - UNII:S85JD8CLBH) Brilliant Green 2.29 mg  in 1 mL
    Gentian Violet (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) Gentian Violet 2.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color GREEN (Violet) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-710-06 100 in 1 BOX 05/01/2004
    1 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 05/01/2004
    Labeler - VistaPharm, Inc. (116743084)
    Establishment
    Name Address ID/FEI Business Operations
    VistaPharm Inc. 116743084 MANUFACTURE(66689-710) , REPACK(66689-710)
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