Proheal Povidone Iodine Swabstick Swab
FDA Label NDC 86173-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Click Industries Llc for the product Proheal Povidone Iodine Swabstick (NDC 86173-003). 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:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Povidone-iodine USP, 10% w/v
(equivalent to 1% titratable Iodine)
Purpose
Antiseptic
Uses:
• Health-care antiseptic for preparation of the skin prior to surgery
• First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns
Warnings:
For external use only. Do not use or apply in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor
Discontinue use if irritation and redness develop.
Consult a doctor in case of deep or puncture wounds • animal bites • serious burns
Stop use and consult a doctor if the condition persists or gets worse.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgery.
For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other Information:
Store at room temperature.
Inactive Ingredients:
Citric acid, Disodium phosphate, Purified water.
Packaging
Povidone Iodine Swabstick (86173003 4)
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