Povidone Iodine Topical Solution Paint Liquid
FDA Label NDC 34645-1041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jianerkang Medical Co., Ltd for the product Povidone Iodine Topical Solution Paint (NDC 34645-1041). 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, stop using this product and ask a doctor if, keep out of reach of children., directions, other information, 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%

(1.0% available iodine)

Purpose

Antiseptic

Use

prepping intact skin and mucous membranes prior to sugery

Warnings

for external use only

avoid use on persons allergic to iodine

Stop Using This Product And Ask A Doctor If

  • skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep Out Of Reach Of Children.

if swallowed, get medical help or contact a Poison Control Center right away

Directions

Patient preoperative prep

  • apply solution to operative site following povidone iodine scrub application
  • using a circular motion, start at incision site and move outward
  • remove all soiled underdrapes
  • do no allow solution to pool

Other Information

  • store at room temperature
  • avoid excessive heat (above 104 degrees F/40 degrees C)
  • protect from freezing
  • latex free

Inactive Ingredients

Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide

Package Labeling

Label1 (Label)

Label1 (Label)

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