Povidone Iodine Scrub Solution
FDA Label NDC 34645-5502

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 Scrub (NDC 34645-5502). 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, stop use and consult a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic

Use

  • Health-care antiseptic for preparation of the skin prior to surgery 
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.

Warnings

For external use only.

Do Not

  • use in the eyes 
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body 
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop. Consult a doctor in case of 
  • deep or puncture wounds
  • animal bites 
  • serious burns.

Stop Use And Consult A Doctor

if the condition persists or gets worse.

Keep Out Of Reach Of Children.

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

Directions

For preparation of the skin prior to surgery

  • clean the affected area remove swab by stick 
  • apply to the operative site prior to surgery. For use as a first aid antiseptic 
  • clean the affected area 
  • apply a small amount of this product on the area 1-3 times daily 
  • may be covered with a sterile bandage 
  • if bandaged,let dry first.

Other Information

store at room temperature: 15°－30°C(59°-86°F)

  • Avoid excessive heat

Inactive Ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

Package Labeling:

Label1 (Label1)

Label1 (Label1)

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