Halodine Nasal Antiseptic Swabstick
FDA Label NDC 78371-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Halodine Llc for the product Halodine Nasal Antiseptic Swabstick (NDC 78371-301). 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 other, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if injuries are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Povidone-Iodine USP, 2.5%

(0.25% Available Iodine)

Purpose

Antiseptic

Uses

  • Antiseptic skin preparation
  • Helps reduce bacteria that can potentially cause skin infection

Warnings

For external use only.

Do Not Use

  • If allergic to iodine
  • In the eyes
  • On children less than 3 years old
  • Over large areas of the body

Stop Use And Ask A Doctor If

irritation and redness develop or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children.

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

Directions

For nasal application

  • Gently blow nose to clear both nostrils. Discard tissue.
  • Open swabstick. Hold tube between thumb and forefinger at blue band with handle up. With other hand, hold handle at base, and bend to snap open. Bend and snap in opposite direction to disconnect swabstick. Remove swabstick from tube.
  • Apply medication. Insert swabstick comfortably into right nostril. Do not insert swab more than 1/4” past nasal opening. Rotate swab within nostril for a total of 15 seconds, using a gentle swirling motion. Discard tube and swabstick.
  • Repeat steps 2 and 3 with second swabstick for left nostril.

    • Note: Do not blow nose. If solution drips, wipe with tissue.

Other Information

  • Single use only; do not reuse
  • Not made with natural rubber latex
  • Store at room temperature; avoid excessive heat

Inactive Ingredients

hydroxyethylcellulose, purified water

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