Label: POVIDONE IODINE- povidone-iodine 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 February 2, 2010

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  • ACTIVE INGREDIENT

    Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • USE

    First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
  • WARNINGS

    For external use only.

    Do not

    • use in the eyes
    • use on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body

    Discontinue use and ask a doctor

    • if condition persists or gets worse
    • for use longer than 1 week



    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Keep out of reach of children

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

  • DIRECTIONS

    • Clean the affected area
    • Apply a small amount of this product to the area 1-3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature 15° - 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    citric acid, glycerin, Makon 8, purified water, sodium hydroxide
  • QUESTIONS


  • LABEL INFORMATION

    EQUALINE

    *Compare to Betadine active ingredient®

    NDC 24385-053-55

    Topical Antiseptic Solution

    10% povidone-iodine solution, USP
    topical antiseptic

    helps reduce bacteria that can potentially cause skin infection

    • water soluble
    • use for first aid and general hygiene
    • helps prevent infection in minor cuts, scrapes and burns

    NET WT 8 FL OZ (236 mL)

    *This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

    Distributed by Albertsons, Inc.
    Boise, Idaho 83726

    We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948 or www.albertsons.com.

    label

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine0.10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-052-55236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2004
    Labeler - Supervalu Inc (006961411)
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