Label: SELECT BRAND POVIDONE IODINE- povidone iodine 10% liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 12, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Povidone-Iodine 10%

    (Equivalent to 1% titrable iodine)

  • Purpose

    Antiseptic

  • Use

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

  • Warnings

    For External Use Only

  • Ask a doctor before use if you have

    • deep punture wounds
    • animal bites
    • serious burns
  • Stop use and consult a doctor if

    • the condition persists or gets worse
    • irritation and redness develop and persits for more than 72 hours
  • When using this product do not

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

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

  • Directions

    For preparation of the skin prior to surgery: Apply to the operative site prior to surgery.

    As a first aid antiseptic: Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

  • Other information

    store at room temperature, 20-25C (68-77F)

  • Inactive Ingredients

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

  • Principal Display Panel

    Label 8 fl oz

    Label 8 fl oz

  • INGREDIENTS AND APPEARANCE
    SELECT BRAND POVIDONE IODINE 
    povidone iodine 10% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-052
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-052-55237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2008
    Labeler - Select Brand Distributors (012578514)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(15127-052) , analysis(15127-052) , pack(15127-052) , label(15127-052)
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