POVIDINE IODINE SWAB [DYNAREX CORPORATION]

POVIDINE IODINE SWAB [DYNAREX CORPORATION]
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NDC 67777-140-01
Set ID e39ef99d-c778-4862-9d93-4074753c47ad
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333
  • ACTIVE INGREDIENT

    Section Text

    Active Ingredient                                  Purpose

    Povidone Iodine 10% v/v                        Antiseptic                          

  • Uses:


    Section Text

    • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
    • For preparation of the skin prior to surgery.
    • Helps reduce bacteria that can potentially cause skin infections.
  • Warnings:

    Section Text

    • FOR EXTERNAL USE ONLY
  • Do not use:

    Section Text


    • As a first aid antiseptic for more than 1 week.
    • In the eyes.
    • Over large areas of the body.
  • Ask a doctor before use if you have:


    • Deep puncture wounds
    • Animal bites
    • Serious burns
  • Stop Use:


    • If irritation and redness develop
    • If condition persists for more than 72 hours, consult a physician.
  • Keep Out Of Reach Of Children

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


  • Directions:

    Tear at notch, remove applicator, use only once.

    As a first aid antiseptic

    • clean affected area
    • apply 1 to 3 times daily
    • may be covered with a sterile bandage, if bandaged let dry.

    For preoperative patient skin preparation

    • clean area
    • apply to operative site prior to surgery using the applicator


  • Other information:

    Store at room temperature.

    Avoid excessive heat

  • Principal Display Panel

    Principal Display Panel

    Povidone_iodine

  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-140-0110 in 1 CASE
    1100 in 1 BOX
    1.3 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/10/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture

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