Label: TM TITUS MEDICAL POVIDONE IODINE- povidone-iodine ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Active Ingredient

    Povidone-Iodine USP (10%)

  • Purpose

    Antiseptic

  • Uses

    Antiseptic skin preparation

  • Warnings

    For external use only

    Do not use if allergic to iodine in the eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

  • ASK DOCTOR

    Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

    Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

  • Directions

    Apply locally as need

  • Other information

    • not made with natural rubber latex
    • for hospital or professional use only
  • Inactive Ingredient

    Glycerin, Propylene Glycol, PEG 1450, Sodium Hydrogen Phosphate, Citric Acid, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TM TITUS MEDICAL POVIDONE IODINE 
    povidone-iodine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81526-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81526-002-01100 in 1 BOX06/21/2021
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/21/2021
    Labeler - Titus Medical LLC (080306309)
    Registrant - Titus Medical LLC (080306309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(81526-002)
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