Active Ingredient
Povidone-Iodine 10%
Povidone Iodine Gel Swabstick Gel
FDA Label NDC 68786-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Povidone Iodine Gel Swabstick (NDC 68786-418). 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 active ingredient, purpose, use(s), warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use(S)
• 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
Do Not Use
• In the eyes or over large areas of the body
• Longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
• Deep or puncture wounds
• Animal bites
• Serious burns
Stop Use And Ask A Doctor If
Condition persists or gets worse
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
• 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.
Other Information
• Store at room temperature 15°-30°C (59°-86°F)
• Avoid excessive heat
Inactive Ingredients
Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR
Questions And Comments?
1-888-369-2739 M-F, 9-5 EST
Label
NDC 68786-418-01
Label (418)
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