NANZ POVIDONE IODINE 5% SOLUTION- povidone iodine 5% solution liquid 
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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Nanz Povidone Iodine 5% Solution

Active Ingredients

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose:

Topical Antifungal

Uses

For the treatment of athlete's foot, jock itch, and ring worm.

For the effective relief of burning, cracking, discomfort, redness, scaling, soreness, and chafing that is associated with jock itch.

Warnings

Do not use on children under 2 years of age unless directed by a doctor. For external use only. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. If irritation occurs or if there is no improvement within 2 weeks, discontinue and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Storage:

Store in dry and dark place at temperature not exceeding 30C. Do not freeze

Label for all sizes

Inactive Ingredients

Anhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-3, potassium iodate, water

Manufactured and Marketed by:

1201258 Ontario Inc. Nanz Pharma

575 Granite Ct.

Pickering,ON

L1W 3K1

Directions:

Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If the condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

To prevent athlete's foot, wash the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

STOP USE AND ASK A DOCTOR IF:

Irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Distributed by:

1201258 Ontario Inc. Nanz Pharma

575 Granite Court

Pickerin, Ontario

L1W 3K1

Canada

Packagae Label

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

NANZ POVIDONE IODINE 5% SOLUTION 
povidone iodine 5% solution liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-050
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM IODATE (UNII: I139E44NHL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83254-050-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
2NDC:83254-050-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
3NDC:83254-050-25225 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
4NDC:83254-050-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
5NDC:83254-050-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
6NDC:83254-050-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
7NDC:83254-050-50250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
8NDC:83254-050-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
9NDC:83254-050-9090 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
10NDC:83254-050-20120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
11NDC:83254-050-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
12NDC:83254-050-1130 mL in 1 POUCH; Type 0: Not a Combination Product02/08/2023
13NDC:83254-050-2260 mL in 1 POUCH; Type 0: Not a Combination Product02/08/2023
14NDC:83254-050-3390 mL in 1 POUCH; Type 0: Not a Combination Product02/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00502/08/2023
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 Pharma256906595label(83254-050) , manufacture(83254-050) , pack(83254-050)

Revised: 5/2023
Document Id: fbfb0719-54fc-50b5-e053-6394a90a7130
Set id: f1ebe0a0-7b08-cc7a-e053-2a95a90af31f
Version: 10
Effective Time: 20230518
 
1201258 Ontario Inc. O/A Nanz Pharma