Label: POVIOFIX ANTISEPTIC- povidone-iodine solution

  • NDC Code(s): 69249-000-00
  • Packager: NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts


  • Active ingredient

    Povidone-iodine 10%

    Purpose

    Antiseptic

  • Uses

    • Surgical hand scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
    • Patient preoperative skin preparation: for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
    • First aid to help decrease the risk of infection in minor cuts, scrapes, and burns.
  • Warnings

    For external use only

    Do not use

    - in the eyes   - over large areas of the body    - longer than 1 week unless directed by a doctor    - if you are allergic to iodine

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Surgical hand scrub (for use without water):

    Patient preoperative skin preparation:

    First-aid antiseptic:

    • clean under nails with a nail pick
    • nails should be maintained with a 1 millimeter free edge
    • place a ‘palmful’ (5 grams) of product in one hand spread on both hands, paying particular attention to the nails, cuticles, and interdigital spaces, and rub into the skin until dry (approximately 1 to 2 minutes)
    • place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into the skin until dry (approximately 30 seconds)
    • clean the area
    • apply product to the operative site prior to surgery
    • clean the affected area. May be covered with a sterile bandage.
    • If bandaged, let dry first.
    • If used as a wet compress bandage lightly. Keep bandage wet with solution.
  • Other information

    • keep the product under 77°F (25°F) and away from food and children
    • keep product sealed after opening
  • Inactive ingredients

    denatured ethyl alcohol, glycerin, polysorbate 20, potassium iodine, trisodium citrate

  • SPL UNCLASSIFIED SECTION

    TO REPORT A SERIOUS ADVERSE EVENT CONTACT [?] YAKUPLU DISTRICT, BEYSAN INDUSTRIAL SITE, BIRLIK STR, NAKIPOGLU CENTRE NO 12. FLOOR 1. BEYLIKDUZU/ISTANBUL/TURKEY TEL: (0212)476 28 68 /476 58 88 FAX: (0212)476 08 98 INFO@NATURELMEDIKAL.COM.TR MADE IN TURKEY





  • PRINCIPAL DISPLAY PANEL

    NATUREL   For People POVIOFIX Antiseptic Solution  Povidone-iodine 10%  33.8 fl oz (1.05 qt) (1 l)

  • Product Label

    PovioFix

  • INGREDIENTS AND APPEARANCE
    POVIOFIX ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69249-000
    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
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69249-000-001 in 1 CARTON09/25/2014
    11000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/25/2014
    Labeler - NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI (355602127)