Halodine Oral Rinse
FDA Label NDC 78371-201
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 Oral Rinse (NDC 78371-201). 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
Active Ingredient
Povidone-Iodine USP, 1.75%
(0.175% Available Iodine)
Purpose
Antiseptic
Uses
- Oral Antiseptic
- First aid to help prevent infection in minor oral irritation caused by dental procedures
Warnings
For external use only.
Do not use • If allergic to iodine • In the eyes • On children less than 3 years old • For more than 7 days unless directed by a dentist or doctor
When using this product: Do not swallow
Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.
Directions
For oral antisepsis in adults and children 3 years of age and older:
- Twist off the narrow end of single ampoule.
- Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
- Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
- Slightly lift chin and tilt head back to gargle, then spit out.
Children under 3 years of age: Consult a dentist or doctor
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
Questions Or Comments?
Packaging
Untitled (78371 201 2)
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