FDA Label for Halodine Oral Rinse
View Indications, Usage & Precautions
Halodine Oral Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Halodine Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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?
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