Label: POVIDONE IODINE swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 17, 2020

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  • Drug Facts

  • Active Ingredient

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

  • Purpose

    Topical Antiseptic

  • Directions

    Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply soltion to injury.

  • Warnings

    • For External Use Only
  • Ask a Doctor before use if you have

    Deep or puncture wounds

    Serious Burns

  • Stop Use

    redness, irritation, swelling or pain persists or increases

    infection occurs

  • Keep Out Of Reach Of Children

    If swallowed, get medical help 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.

  • Other Information

    Store at room temperature away from light keep from freezing or excessive heat

  • Inactive Ingredient

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

  • PRINCIPAL DISPLAY PANEL

    Povidone Iodine Swab

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-116
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68183-116-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/14/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2015
    Labeler - Custom Kits Company Inc (928643712)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(68183-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Kits Company Inc928643712repack(68183-116) , relabel(68183-116)
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