SUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]

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SUNMARK POVIDONE-IODINE TOPICAL (POVIDONE-IODINE) SOLUTION [MCKESSON]
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NDC 49348-622-37, 49348-622-38
Set ID acc349d6-2875-4814-aa6e-828fffec7f07
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • sunmark Povidone-Iodine 10% Topical Solution


  • Active Ingredient

    Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

  • Purpose

    Antiseptic

  • Uses

    First aid antiseptic to prevent infection in minor cuts, burns.

  • Warnings

    For external use only.

    Do not:

    • use in the eyes.
    • use longer than 1 week unless directed by a doctor.
    • use on individuals who are allergic or sensitive to iodine.
    • apply over large areas of the body.

    Stop use and consult a doctor if

    • condition persists or gets worse.
    • irritation and redness develop and persist for more than 72 hours.

    Ask a doctor in case of:

    • deep or puncture wounds
    • animal bites
    • serious burns.

    Keep out of reach of children.

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

  • Directions

    • Clean the affected area
    • Apply a small amount on the area 1 to 3 times daily.
    • May be covered with a sterile bandage.
    • If bandaged, let dry first.
  • Other Information

    Store at room temperature, 20-25 0 C (68-77 0 F).

  • Inactive Ingredients:

    Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

  • sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38)

    Povidone 8 ozPovidone 16 oz

  • INGREDIENTS AND APPEARANCE
    SUNMARK POVIDONE-IODINE TOPICAL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-622
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-622-37237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    2NDC:49348-622-38473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/28/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(49348-622) , analysis(49348-622) , pack(49348-622) , label(49348-622)
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