Poviofix Antiseptic
FDA Label NDC 69249-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naturel Medikal Ilac Sanayi Ve Ticaret Limited Sirketi for the product Poviofix Antiseptic (NDC 69249-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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