Povidone Iodine Prep Pad Solution
FDA Label NDC 34645-5500

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 Prep Pad (NDC 34645-5500). 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, use, warnings, do not, stop use and consult a doctor, ask 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.

Active Ingredient

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)

Use

First aid to help prevent infection in minor cuts,scrqpes,and burns

Warnings

For external use only.

Do Not

  • use in the eyes 
  • apply over large areas of the body. 
  • use on individuals who are allergic or sensitive to iodine.

Stop Use And Consult A Doctor

  • if the condition persists or gets worse 
  • for use longer than 1 week.

Ask A Doctor

in case of deep or puncture wounds, animal bites,serious burns.

Keep Out Of Reach Of Children.

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

Directions

  • Clean the affected area 
  • Apply product on the area 1-3 times daily and discard 
  • May be covered with a sterile bandage when dry

Other Information

  • Avoid excessive heat 
  • store at room temperature: 15°-30°C(59°-86°F)

Inactive Ingredients

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

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