Halodine Nasal Antiseptic
FDA Label NDC 78371-501
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 78371-501). 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, otc - keep out of reach of children, directions, other information, 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
Uses
• Kills germs • Helps reduce bacteria that cause infections
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For nasal application to skin inside of nostrils in adults and children 3 years of age and older:
1. Gently blow nose to clear both nostrils. Discard tissue.
2. Remove cap.
3. Close one nostril and put only the tip of spray nozzle in other nostril. Aim slightly away from center of nose.
4. While sniffing gently, press down the spray nozzle twice. You'll feel a light mist in your nose. Breathe out through your mouth.
5. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap.
Children under 3 years of age: Consult a doctor.
Other Information
• Not made with natural rubber latex • Store at room temperature; avoid excessive heat
Inactive Ingredients
hydroxyethylcellulose, purified water
Questions Or Comments?
Packaging
Image (78371 501 01)
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