POVIDONE IODINE- povidone iodine oral rinse 0.5% liquid

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Purdue Oral Rinse Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine oral rinse 0.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT (UNII: V95R5KMY2B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9136-98	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/06/2021
2	NDC: 0395-9136-23	20 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/06/2021

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0395-9136) , analysis(0395-9136) , pack(0395-9136) , label(0395-9136)