Active Ingredient
Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)
Povidone-iodine Swabstick
FDA Label NDC 10819-3800
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 Povidone-iodine Swabstick (NDC 10819-3800). 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
- For preparation of the skin prior to surgery
- Helps reduce bacteria that can potentially cause skin infection
Warnings
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.
Directions
For preparation of the skin prior to surgery
- clean the treatment area
- remove applicator by end of swabstick
- 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.
Package Label.Principal Display Panel
S41350 web NDC# 10819-3800-1
Web 1 (Sjk1250 2 Pvp Us 1s Web Po443042 Jl Aprvd Clean)
S41350 box NDC# 10819-3800-1
S41125 web NDC# 10819-3800-2
Web 2 (Sjk1251 Pvp Us 3s Web Po443041 Jl Aprvd Clean)
S41125 box NDC# 10819-3800-2
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