POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC- povidone-iodine solution

Povidone Iodine Solution First Aid Antiseptic by

Drug Labeling and Warnings

Povidone Iodine Solution First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone-iodine, 10%

(1% available iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• burns

Warnings

For external use only

Do not use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children.

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

Directions

• clean the affected area
• apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first.

Other information

store between 15° - 30°C (59°-86°F)

Inactive ingredients

 C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Disclaimer

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Betadine ®Antiseptic 10% Povidone-iodine First Aid Antiseptic.

Adverse reaction

Distributed by:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Principal display panel

Swan ®

POVIDONE-IODINE SOLUTION 10%

FIRST AID ANTISEPTIC

• HELPS PREVENT INFECTION IN MINOR CUTS, SCRAPES, AND BURNS

Compare to Betadine ®First Aid Antiseptic*

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-13 PARETH-9 (UNII: 9BXD858P37)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-050-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2009
2	NDC: 11344-050-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/07/2009

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11344-050)