Zonsen Povidone-iodine Prep Pad
FDA Label NDC 72932-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wuhan Zonsen Medical Products Co., Ltd. for the product Zonsen Povidone-iodine Prep Pad (NDC 72932-003). 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 ingredients, purpose, use, warnings, do not use, stop use and ask a doctor if, 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 Ingredients

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

Purpose

Antiseptic

Use

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

Warnings

  • For external use only.

Do Not Use

  • in the eyes.
  • longer than 1 week unless directed by a doctor.
  • on individuals who are allergic or sensitive to iodine.
  • or apply over large areas of the body.

Stop Use And Ask A Doctor If

  • If irritation and redness develop.
  • condition persist for more than 72 hours.
  • In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Keep Out Of Reach Of Children.

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

Directions

  • Clean the affected area.
  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery 
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Inactive Ingredients:

Sodium hydroxide, water

Other Information

  • Protect from freezing
  • Avoid excessive heat.

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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