Antiseptic Povidone Iodine Prep Pad Cloth
FDA Label NDC 84219-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by M-star (hubei) Health&care Products Co., Ltd. for the product Antiseptic Povidone Iodine Prep Pad (NDC 84219-006). 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 drug facts, active ingredients, purpose, use:, warnings:, keep out of reach of children, do not use:, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Providone-Iodine 10% w/w (1% available iodine)

Purpose

Antiseptic

Use:

First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.

Warnings:

  • For external use only 
  • Single use only

Keep Out Of Reach Of Children

Do Not Use:

  • in the eyes
  • over large areas of the body
  • as a first aid antiseptic for longer than one week unless 
  • directed by a physician
  • on individuals who are sensitive or allergic to iodine
  • if package is damaged or open

Stop Use And Ask A Doctor If

  • irritation,redness,or symptoms develops
  • if the condition persists or gets worse.

Directions:

  • Clean the treatment area
  • Apply to the treatment area or operative site before surgery

Inactive Ingredient:

Purified water

Question?

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Package Labeling:

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