POVIDONE IODINE- povidone-iodine spray 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]

Active Ingredient

Povidone-Iodine 5%

(0.5% available iodine)

Warnings

For external use only.

Do not use:

• In the eyes
• Over large areas of the body
• If you are allergic to povidone-iodine or any other ingredients in this preparation

Ask a doctor before use if you have:

• Deep or puncture wounds
• Serious burns
• Animal bites

Stop and ask a doctor if:

• The condition persists or gets worse
• You need to use this product for more that 1 week

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

Inactive ingredients:

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

Directions:

• Clean the affected area
• Spray a small amount of product on the area 1 to 3 times daily
• May be covered with a sterile bandage
• If bandaged, let dry first

Uses

First aid to help prevent infection in minor

• cuts
• scrapes
• burns

Purpose

Antiseptic

SPL UNCLASSIFIED SECTION

Drug Facts

Principal Display Panel

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine spray 5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM IODATE (UNII: I139E44NHL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9129-93	89 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/23/2020

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(0395-9129) , pack(0395-9129) , label(0395-9129) , analysis(0395-9129)