Label: FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL

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 7, 2020

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  • Active Ingredient:

    Povidone-Iodine Solution 10%

  • Purpose:

    Antiseptic

  • Use:

    First aid antiseptic to help prevent skin infection.

  • Warnings:

    For external use only.

  • DO NOT USE

    Do not use▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

    ▪ longer than 1 week unless directed by a doctor.

    Ask doctor before use if you have ▪ deep or puncture wounds ▪ animal bites ▪ serious burns.

    Stop use and ask a doctor if ▪ conditions worsen or clear up and then recur

    ▪ the condition persists for more than 7 days

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

  • Directions:

    Open packet and wipe affected area. Apply 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:

    alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

    purified water, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    Carton Label Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-8112(NDC:65517-0034)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-8112-0110 in 1 CARTON01/07/2020
    10.5 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0924-8112-000.5 mL in 1 POUCH; Type 0: Not a Combination Product01/07/2020
    3NDC:0924-8112-0250 in 1 CARTON01/07/2020
    30.5 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-8112-03100 in 1 CARTON01/07/2020
    40.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/07/2020
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-8112) , repack(0924-8112)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-8112) , repack(0924-8112)
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