Halodine Oral Antiseptic
FDA Label NDC 78371-401

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 Oral Antiseptic (NDC 78371-401). 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, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Purpose

Antiseptic

Packaging

Image (7837140101)

Image (7837140101)

Image (78371401 01)

Image (78371401 01)

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