Pvp-i Prep Pads Foil-foil Swab
FDA Label NDC 65517-0034

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dukal Llc for the product Pvp-i Prep Pads Foil-foil (NDC 65517-0034). 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:, use:, warnings:, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, 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%

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 Foil Pouch Label

DUKAL™
CORPORATION

REF 882

STERILE

Povidone-Iodine
Prep Pad

For Professional and Hospital Use

Not Made with Natural Rubber Latex

1
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

2

Principal Display Panel (PVP-I Prep Pads Foil Pouch Label)

Principal Display Panel (PVP-I Prep Pads Foil Pouch Label)

Principal Display Panel - Pvp-I Prep Pads Foil 865-8000 Case Label

DUKAL™
CORPORATION

REF 882-8000

STERILE

POVIDONE-IODINE
PREP PADS

For Professional and Hospital Use

Not Made with Natural Rubber Latex

8000/Case

1/Pack

2

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973025023

Principal Display Panel (PVP-I Prep Pads Foil 865-8000 Case Label)

Principal Display Panel (PVP-I Prep Pads Foil 865-8000 Case Label)

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