Label: POVIDONE-IODINE solution

  • NDC Code(s): 46414-7777-2, 46414-7777-3
  • Packager: James Alexander Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • Drug Facts

  • Active Ingredients (each swab)

    10% Povidone Iodine Solution USP, (1% available Iodine)

  • Purpose

    Topical Antiseptic

  • Uses

    To treat minor skin cuts and abrasions.

  • Warnings

    For external use only.

    Ask a doctor before use if you have • deep or puncture wounds • serious burns

    Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases
                                                    • infection occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

  • Other Information

     Store at room temperature away from light. Keep from freezing or excessive heat.

  • Inactive Ingredients

    Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

  • Questions?

    Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.

  • SPL UNCLASSIFIED SECTION

    DISPENSING SOLUTIONS®

    JAMES ALEXANDER CORPORATION
    Blairstown, NJ• (908) 362-9266
    Product information and MSDS available on-line at:
    www.james-alexander.com

    Void of Aqueous

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-7777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46414-7777-310 in 1 CONTAINER02/14/1976
    10.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:46414-7777-2100 in 1 CONTAINER02/14/1976
    20.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/14/1976
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(46414-7777)
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