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FDA LABEL GENERIC: Povidone-iodine MFR: Sion Biotext Medical Ltd

Povidone-iodine 0.1 Mg/mg Topical Gel

Povidone-Iodine 10%

Antiseptic

INDICATIONS AND USAGE

• For preparation of the skin prior to surgery

• First aid to help prevent infection in minor cuts, scrapes, and burns

• For venipuncture skin preparation

WARNINGS

For External Use Only

• In the eyes or over large areas of the body

• Longer than 1 week unless directed by a doctor

• Deep or puncture wounds

• Animal bites

• Serious burns

Condition persists or gets worse

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

DOSAGE AND ADMINISTRATION

• Tear at notch • Remove applicator • Use only once

As a first aid antiseptic:

• Clean affected area

• Apply 1 to 3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

For preoperative patient skin preparation:

• Clean area

• Apply to operative site prior to surgery

For Venipuncture skin preparation:

• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.

• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.

• Allow site to dry for approximately 30 seconds.

• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

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