FDA Label for Pvp-i Prep Pads Paper-foil
View Indications, Usage & Precautions
Pvp-i Prep Pads Paper-foil Product Label
The following document was submitted to the FDA by the labeler of this product Dukal Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient:
Povidone Iodine USP 10%
Purpose:
Antiseptic
Use:
For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.
Warnings:
For external use only.
Otc - Do Not Use
Do not apply to persons allergic to iodine. Do not use in the eyes.
Otc - Ask Doctor
- Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Otc - Stop Use
- Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
- Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Directions:
Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.
Other Information:
1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.
Inactive Ingredients:
Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.
Principal Display Panel - Pvp-I Prep Pads Paper/Foil Pouch Label
Dukal
Povidone-Iodine
Prep Pad
Non-Sterile
Antiseptic
For Professional and Hospital Use
Not Made with Natural Rubber Latex
Manufactured For: Dukal LLC
1(800)243-0741 / Ronkonkoma, NY 11779
Made in China
Dukal is a trademark registered in the
US Patent & Trademark Office by Dukal, LLC
1 Per Pouch / 2 / NDC 65517-0039-1 / REF 914
* Please review the disclaimer below.
