Jianze Povidone Iodine Scrub
FDA Label NDC 50666-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Changzhou Jianze Sanitary Material Co., Ltd. for the product Jianze Povidone Iodine Scrub (NDC 50666-006). 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 jianze povidone iodine scrub swabstick, active ingredient, purpose, use:, warnings:, 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

Jianze Povidone Iodine Scrub Swabstick


Active Ingredient

Povidone Iodine USP, 10% W/V (equivalent to 1% tiratable 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 on the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large area 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

It the condition persists or gets worse.

Keep Out Of Reach Of Children.

In 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 degrees - 30 degrees C (59 degrees - 86 degrees F)

Inactive Ingredients:

Citric Acid, Purified Water, Sodium Hydroxide, Nonoxynol-10, Glycerin

Jianze Povidone Iodine Scrub Swabstick 25 Count Of 3 Swabsticks (50666-006-01)


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