Label: AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION- povidone iodine 5 % topical solution solution

  • 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 January 26, 2023

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  • ACTIVE INGREDIENT

    Povidone Iodine IP 5% w/v.

  • INACTIVE INGREDIENT

    1. Citric acid
    2. Disodium hydrogen O- phosphate, Potassium iodate
    3. Glycerin
    4. Purified water

  • USE

    • For preparation of the skin prior to surgery
    • Helps reduce bacteria that potentially can

    cause skin infection

  • QUESTIONS

    Call. 1-800-103-7321,

    E-mail : info@aurolab.com
    Web : www.aurolab.com

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a Poison Control Center right away.

  • STOP USE

    Irritation, sensitization, or allergic reaction
    occurs and lasts for 72 hours. These may
    be signs of a serious condition.

  • DO NOT USE

    1. If you are allergic to povidone-iodine or
      any other ingredients in this preparation
      In the eyes
  • WARNINGS

    For External use only

  • INDIACATIONS AND USAGE

    Prolonged exposure to wet solution may
    cause irritation or, rarely, severe skin
    reactions
    In pre-operative prepping, avoid “pooling”
    beneath the patient

  • Purpose

    Antiseptic

  • Dose

    • Clean the area and apply product to the operative site prior to surgery.
    • The solution can be used to irrigate the cornea and conjunctiva with a sterile bulb syringe prior to surgery.
    • After the solution has been left in contact for two minutes flush the residual prep solution using a sterile saline solution.
  • PACKAGE CARTON

    Povidone

  • INGREDIENTS AND APPEARANCE
    AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION 
    povidone iodine 5 % topical solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POTASSIUM IODATE (UNII: I139E44NHL)  
    DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16030-601-055 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/31/2023
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-601)
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