Label: AMSINO 10 POVIDONE-IODINE SOLUTION 3 4 FLUID OUNCE- povidone-iodine liquid

  • NDC Code(s): 59050-265-01
  • Packager: Changzhou Maokang Medical Products Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-lodine 10%USP

    Purpose

    Antiseptic

  • Use

    for antiseptic skin preparation

  • Warnings

    do not use

    • if allergic to lodine
    • do not use in the eyes

    Stop use and ask a doctor if

    • redness,irritation,swelling or pain persists or increases
    • infection occurs

    Keep out of reach of children.

    In case of accidental ingestion,seek professional assistance or consult a Poison Control Center immediately. Avoid pooling beneath patient.

    Ask a doctor before use

    if injuries are

    • deep or puncture wounds
    • serious burns
  • Directions

    Apply product to skin as needed.

  • Other information

    • 1% titratable iodine
    • for hospital or professional use only
  • Inactive ingredients:

    Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purified water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMSINO 10 POVIDONE-IODINE SOLUTION 3 4 FLUID OUNCE 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-265-0122 mL in 1 POUCH; Type 0: Not a Combination Product02/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/28/2023
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-265)
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