Halodine Nasal Antiseptic
FDA Label NDC 78371-101

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 (NDC 78371-101). 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.

Label Section Quick Index

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Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% 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 single ampoule by tearing off the narrow end along line. To avoid spill while opening, only hold flat foil around raised body of ampoule and maintain ampoule with narrow end pointing up.
  • Place narrow end of ampoule at right nostril and gently pinch left nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through right nostril. Discard ampoule.
  • Open second ampoule by tearing off the narrow end along line. Avoid spill.
  • Place narrow end of ampoule at left nostril and gently pinch right nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through left nostril. Discard ampoule.

    • 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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