POVIDINE IODINE SOLUTION [CHAIN DRUG CONSORTIUM, LLC]

POVIDINE IODINE SOLUTION [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-013-94
Set ID 60e35882-6f9f-489d-8a49-8d61ce0db7bf
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active Ingredient                                  Purpose

    Povidone Iodine 10% v/v                        Antiseptic                          

  • Uses: povidone iodine prep


                 povidone iodine prep

    • 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:

    • FOR EXTERNAL USE ONLY
  • Do not use:


    • 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


  • Inactive Ingredient:

    Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water
  • INDICATIONS & USAGE

    For use as an

    • first aid antiseptic
    • pre-operative skin preperation
  • Principal Display Panel

    povidone_iodine_prep

    povidone_iodine_prep


  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-013
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-013-946 in 1 CASE
    1236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/17/2011
    Labeler - Chain Drug Consortium, LLC (101668460)

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