BETADINE ANTISEPTIC ORAL RINSE- povidone-iodine solution
Atlantis Consumer Healthcare, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredient
Povidone-iodine,
0.5% (0.05% available iodine)
Purpose
Oral
Antiseptic
Uses
- 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 or 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
When using this product
- do not get into eyes. If contact occurs, rinse eyes thoroughly
with water. If irritation persists, consult a doctor
- do not swallow
- do not use with hydrogen peroxide
Stop use and ask a doctor or dentist if
- symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops
If pregnant
or breast-feeding, ask a health professional before use.
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 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C
(59⁰-86⁰F)
- may stain clothing or dental work
- avoid contact with jewelry, especially silver
Inactive ingredients
citric acid,
flavor, glycerin, propylene glycol, purified water, saccharin sodium,
sodium hydroxide
Dist. by: Avrio Health L.P.
Stamford, CT 06901-3431
305765-0B
Betadine
Oral Rinse
NDC: 67618-182-08
Atlantis Consumer Healthcare, Inc.
