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  5. Label Information: Poviofix Antiseptic

FDA Label for Poviofix Antiseptic

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTHER
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    15. PRODUCT LABEL

Poviofix Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Naturel Medikal Ilac Sanayi Ve Ticaret Limited Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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):

  • 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)

    • Patient preoperative skin preparation:

    • clean the area
    • apply product to the operative site prior to surgery

      • First-aid antiseptic:

      • 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


Other



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
[email protected]
MADE IN TURKEY


Package Label.Principal Display Panel



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


Product Label




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