Medichoice Povidone-iodine Prep Pad Cloth
FDA Label NDC 39892-0808

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Povidone-iodine Prep Pad (NDC 39892-0808). 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, do not use, ask a doctor before use, stop use and ask a doctor, 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

Antiseptic skin preparation

Warnings

For external use only.

Do Not Use

  • if allergic to iodine

Ask A Doctor Before Use

if injuries are deep wounds, puncture wounds, or serious burn

Stop Use And Ask A Doctor

if infection occurs or if redness, irritation, swelling or pain persists or increases

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center Immediately

  • Avoid excessive heat. Store at room temperature.

Directions

  • Apply locally as needed.

Other Information

  • 1% titratable iodine
  • For hospital or professional use only.

Inactive Ingredients

Purified water, Glycerin, Nonyl nonoxynol-10, Citric acid, Sodium hydroxide

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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