Active Ingredient
Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)
Pvp-i Prep Pad Swab
FDA Label NDC 10819-3801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Professional Disposables International, Inc. for the product Pvp-i Prep Pad (NDC 10819-3801). 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, uses, warnings, directions, other information, inactive ingredients, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- A broad spectrum antiseptic for topical application for preparation of skin prior to surgery.
Warnings
For external use only
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.
Directions
- Tear at notch
- Clean the treatment area
- Remove swab
- Apply to the operative site prior to surgery
- Allow to dry
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients
Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide
Do Not Use
Do not use
- in the eyes, nose or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center.
Principal Display Panel
Packet 10819-3801-1
Box 10819-3801-2
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