Private Label Povidone Iodine Oral Rinse 0.5%
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Povidone-Iodine 0.5%
(0.05% available iodine)
Purpose
Oral Antiseptic
Use
For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.
Warnings
Do not use this product
- for more than 7 days unless directed by a dentist of doctor
- in children under 12 years of age unless directed by a dentist or doctor
- if you are allergic to povidone-iodine or any other ingredients in this product
- if you have any thyroid conditions
Stop use and consult a doctor if
Symptoms do not improve in 7 days.
Irritation, pain or redness persists or worsens.
Swelling, rash or fever develops.
When using this product do not
Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.
Swallow.
Use with hydrogen peroxide.
Keep out of reach of children.
In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Use full strength.
- Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
- Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
- With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
Other information
- Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F).
- May stain clothing or dental work.
- Avoid contact with jewelry, especially silver.
Inactive Ingredients
Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.
Do not use this product
- For more than 7 days unless directed by a dentist or doctor.
- If you are allergic to povidone-iodine or any other ingredients in this product.
- If you have any thyroid conditions.
If pregnant or breast-feeding
Ask a health professional before use.