Label: FIRST AID ANTISEPTIC- 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 November 21, 2014

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  • ACTIVE INGREDIENT

    Povidone-iodine, 10%
    ( equivalent to 1% available iodine)

  • purpose

    First aid antiseptic

  • Uses

    First aid to help prevent the rise of infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water
    • do not apply over larges areas of the body
    • do not use longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor if 

    condition persists or gets worse

  • 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 on the area 1 to 3 times daily
    • may be covered with a sterile bandage.  If bandaged, let dry first
  • Other information

    Store at room temperature

  • inactive ingredients

    citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

  • Disclaimer

    This product is not manufactured or distributed by Purdue Products L.P.,  distributor of Betadine

  • Adverse Reactions Section

    Distributed by SUPERVALU, INC

    Eden Prairie, MN 55344 USA

    Contact us at 1-877-932-7948

    or www.supervalu-ourownbrands.com

  • principal display panel

    Compare to Betadine

    active ingredient

    EQUALINE

    povidone-iodine

    solution

    10%

    first aid antiseptic

    • helps prevent infection in cuts, scrapes, and minor burns
    • forms a protective film
    • virtually non-irritating and non-staining to the skin

    8 FL OZ (237mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-017
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-017-34237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/08/2012
    Labeler - Supervalu Inc (006961411)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon790752542manufacture(41163-017)
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