POVIDONE IODINE- povidone iodine gargle 0.5% liquid

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by 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

Antiseptic

Use

For the temporary relief of occasional sore throat.

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

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 gargling is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DO NOT SWALLOW

Adults and children 12 years and older:

• Gargle with 10mL full strength for 30 seconds, then spit out.
• Use only with dosing cup provided.
• Use up to 4 times daily.

Children under 12:

• Do not use.

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 Gargle Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine gargle 0.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-908
Route of Administration	ORAL

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: 82645-908-98	1 in 1 CARTON	06/10/2020
1		237 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/10/2020

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(82645-908) , analysis(82645-908) , pack(82645-908) , label(82645-908)