Full Care Povidone Iodine Solution
FDA Label NDC 65028-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shaoxing Fuqing Health Products Co., Ltd. for the product Full Care Povidone Iodine Solution (NDC 65028-006). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - ask doctor, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Povidone-Iodine USP 10% (1.0% Available Iodine)

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

Use: Prepping Intact Skin and Mucous Membranes Prior to Surgery

Warnings

Warnings:

For external use only

Avoid use on persons allergic to iodine

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

Otc - Ask Doctor

Stop use and ask a doctor if

  • Skin shows symptoms of irritation, sensitivity, redness, pain, or swelling.

Dosage & Administration

Directions: Patient Preoperative Prep:

Use full strength. Apply solution to preoperative site following povidone iodine scrub application. Use a circular motion,start as incision site and move onward. Remove all soiled underdrapes. Do not allow solution to pool.

Other Safety Information

Other information

  • Store at room temperature.
  • Avoid excessive heat (above 104F/40C)
  • Protect from freezing)
  • Laetx free

Inactive Ingredient

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

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Label (006)

Label (006)

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