BETADINE ANTISEPTIC ORAL RINSE- povidone-iodine solution

BETADINE Antiseptic Oral Rinse by

Drug Labeling and Warnings

BETADINE Antiseptic Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma L.P., Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PREGNANCY OR BREAST FEEDING

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

SPL UNCLASSIFIED SECTION

Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
305765-0B

PRINCIPAL DISPLAY PANEL

Betadine Oral Rinse
NDC: 67618-182-08

INGREDIENTS AND APPEARANCE

BETADINE ANTISEPTIC ORAL RINSE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-182
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-182-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/08/2021

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	MANUFACTURE(67618-182)