Label: FULL CARE POVIDONE IODINE SOLUTION- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 29, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP 10% (1.0% Available Iodine)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use: Prepping Intact Skin and Mucous Membranes Prior to Surgery

  • WARNINGS

    Warnings:

    For external use only

    Avoid use on persons allergic to iodine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

  • ASK DOCTOR

    Stop use and ask a doctor if

    • Skin shows symptoms of irritation, sensitivity, redness, pain, or swelling.
  • DOSAGE & ADMINISTRATION

    Directions: Patient Preoperative Prep:

    Use full strength. Apply solution to preoperative site following povidone iodine scrub application. Use a circular motion,start as incision site and move onward. Remove all soiled underdrapes. Do not allow solution to pool.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature.
    • Avoid excessive heat (above 104F/40C)
    • Protect from freezing)
    • Laetx free
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FULL CARE POVIDONE IODINE SOLUTION 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-006
    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
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65028-006-0159 mL in 1 BOTTLE
    2NDC:65028-006-0288.5 mL in 1 BOTTLE
    3NDC:65028-006-03109 mL in 1 BOTTLE
    4NDC:65028-006-0450 mL in 1 BOTTLE
    5NDC:65028-006-05100 mL in 1 BOTTLE
    6NDC:65028-006-06150 mL in 1 BOTTLE
    7NDC:65028-006-07200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/22/2014
    Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-006)
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