Halodine Nasal Antiseptic
FDA Label NDC 78371-101

10 label sections · Submitted to the FDA by Halodine Llc · 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 drug facts, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    • Ask a doctor before use if injuries are

    • Deep or puncture wounds
    • Serious burns

      • Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Directions

For nasal application

  • Gently blow nose to clear both nostrils. Discard tissue.
  • Open single ampoule by folding the narrow end along line. To avoid spill while opening, 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 folding 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

Packaging

Untitled (78371 101 1)

Untitled (78371 101 1)

* Please review the disclaimer below.