Proheal Povidone Iodine Prep Pads Cloth
FDA Label NDC 86173-002
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 Prep Pads (NDC 86173-002). 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 • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic for more than 1 week unless directed by a doctor
Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious wounds
Stop use and ask a doctor if • condition worsens or persists for more than 72 hours • irritation and redness develops
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 the pad, 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 Monohydrate, Sodium Phosphate Dibasic, Water
Packaging
Proheal Povidone Iodine Prep Pads (86173002 4)
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