Cliniclean Povidone-iodine Prep Solution
FDA Label NDC 69464-802

12 label sections · Submitted to the FDA by Hr Healthcare · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hr Healthcare for the product Cliniclean Povidone-iodine Prep (NDC 69464-802). 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 drug facts, active ingredient, purpose, use, warnings, stop use and ask a doctor if, keep out of reach of children., ask a doctor before use if injuries are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Povidone-Iodine 10%w/v

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

  • do not use if allergic to iodine.

  • do not use in the eyes

Stop Use And Ask A Doctor If

  • redness, irritation, swelling or pain persists or increases.

  • infection occurs

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately.

Avoid pooling beneath patient.

Ask A Doctor Before Use If Injuries Are

  • deep or puncture wounds
  • serious burns

Directions

Apply locally as needed.

Other Information

  • 1% titratable iodine
  • for hospital or professional use only

Inactive Ingredients

Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purified water

Package Labelling:

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