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.
Label Section Quick Index
Active Ingredient
Povidone-Iodine USP, 1.25%
(0.125% Available Iodine)
Purpose
Antiseptic
Packaging
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