Povidone Iodine Swabsticks
FDA Label NDC 65028-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shaoxing Fuqing Health Products Co., Ltd. for the product Povidone Iodine Swabsticks (NDC 65028-008). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - ask doctor, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Povidone-Iodine USP (10%)

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

Use: Antiseptic skin preparation

Warnings

Warnings:

Do not use

  • if allergic to iodine
  • in the eyes

    • For external use only

    Avoid "pooling" beneath patients.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Otc - Ask Doctor

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

    • Stop use and ask a doctor if

    • redness, irritation, swelling, or pain persists or increases
    • infection occurs

Dosage & Administration

Apply locally as need

Other Safety Information

Other information

  • For hospital or professional use only

Inactive Ingredient

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

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