POVIDONE IODINE- povidone iodine antiseptic 5% solution solution 
1201258 Ontario Inc. O/A Nanz Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Povinanz 5% Antiseptic Solution

Active Ingredient

Povidone-Iodine USP 5%

0.5% available iodine

Purpose:

Topical Antiseptic

Warnings:

For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and ask a doctor if the condition persists or gets worse. Stop use and ask doctor if redness, irritation, swelling, or pain persists, and infection occurs. Do not use longer than 1 week unless directed by a doctor. Do not use if allergic to iodine, in the eyes. Avoid pooling beneath the patient. Avoid excessive heat. Store at room temperature.

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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.

Use:

Antiseptic skin preparation

Other information

- not made with natural rubber latex

- for hospital and professional use only.

Inactive ingredients:

InAnhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-9, potassium iodate, water

Questions:

Nanz Pharma Inc., 575 Granite Court, Pickering, ON, L1W 3K1, Canada

Label for 5% solution

Label for all povidone iodine 5 percentLabel for all povidone iodine 5 percent

POVIDONE IODINE 
povidone iodine antiseptic 5% solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM IODATE (UNII: I139E44NHL)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83254-105-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
2NDC:83254-105-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
3NDC:83254-105-25225 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
4NDC:83254-105-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
5NDC:83254-105-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
6NDC:83254-105-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
7NDC:83254-105-50250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
8NDC:83254-105-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
9NDC:83254-105-9090 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
10NDC:83254-105-20120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
11NDC:83254-105-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2023
12NDC:83254-105-1130 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
13NDC:83254-105-2222.5 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
14NDC:83254-105-6660 mL in 1 POUCH; Type 0: Not a Combination Product06/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/07/2023
Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
Establishment
NameAddressID/FEIBusiness Operations
1201258 Ontario Inc. O/A Nanz Pharma256906595manufacture(83254-105) , pack(83254-105) , label(83254-105)

Revised: 5/2023
Document Id: fd9f4d82-1f82-b1f6-e053-6394a90a33d8
Set id: fd9f7bc0-bd91-2ca1-e053-6394a90a9988
Version: 1
Effective Time: 20230525
 
1201258 Ontario Inc. O/A Nanz Pharma