MAJOR POVIDONE IODINE (POVIDONE-IODINE) OINTMENT [MAJOR PHARMACEUTICALS]

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MAJOR POVIDONE IODINE (POVIDONE-IODINE) OINTMENT [MAJOR PHARMACEUTICALS]
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NDC 0904-1102-31
Set ID bf631ed8-1080-4586-ae54-57b93d0eb158
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Povidone Iodine USP10% w/w (available iodine 1%)

  • Purpose

    Antiseptic-germicidal

  • Uses

    for the treatment of:

    • minor wounds
    • infections
    • kills bacteria promptly
  • Warnings

    For external use only.

    Do not use

    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

    When using this product

    • Avoid contact with eyes.

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation or swelling occurs or pain persists

    Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • apply directly to affected area
    • may be bandaged
  • Other information

    • Store at controlled room temperature 15°-30°C (59°-86°F).
    • Close cap tightly after use.
    • For control no. and expiration date, see carton and/or crimp of tube.
    • Will not stain natural fabrics.
    • Protect from freezing.
  • Inactive ingredients

    glycerin, PEG-6, PEG-32, propylene glycol

  • Questions?

    Adverse Drug Event call (800)616-2471

    Dist. By MAJOR PHARMACEUTICALS

    31778 Enterprise Drive, Livonia, Ml 48150 USA

    Re-Oder No. 100433 M-101

  • Principal Display Panel – 1 oz. Tube

    Major® NDC 0904-1102-31

    Povidine™

    FIRST AID OINTMENT

    NET WT. 1 OZ (28.35 g) *Compare to

    POVIDINE – IODINE 10% Active Ingredient of

    AVAILABLE IODINE 1% Betadine® Ointment

    Principal Display Panel – 1 oz. Tube

  • Principal Display Panel – 1 oz. Carton

    Major® NDC 0904-1102-31

    Povidine™ *Compare to

    FIRST AID OINTMENT Active Ingredient of

    NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment

    Principal Display Panel – 1 oz. Carton

  • INGREDIENTS AND APPEARANCE
    MAJOR POVIDONE IODINE 
    povidone-iodine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-1102-311 in 1 CARTON08/14/2006
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/14/2006
    Labeler - Major Pharmaceuticals (191427277)
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