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 December 13, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!