Povidone Iodine by 1201258 Ontario Inc. O/A Nanz Pharma Povinanz Ointment 5%

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by 1201258 Ontario Inc. O/A Nanz Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POVIDONE IODINE- povinanz ointment ointment 
1201258 Ontario Inc. O/A Nanz Pharma

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Povinanz Ointment 5%

Active Ingredients

5% Povidone Iodine Solution USP

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, disuse 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

Povidone Iodine Label for all sizes

Inactive Ingredients:

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400

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 atto 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 them 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 with 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 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
1201258 Ontario Inc. Na
Canada

Manufactured and Marketed by:

Nanz Pharma
575 Granite Ct.
Pickering,ON
L1W 3K1

Label

POVIDONE IODINE 
povinanz ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-500-50	150 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
2	NDC: 83254-500-10	100 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
3	NDC: 83254-500-90	90 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
4	NDC: 83254-500-60	60 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
5	NDC: 83254-500-01	10 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
6	NDC: 83254-500-15	15 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
7	NDC: 83254-500-05	5 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
8	NDC: 83254-500-11	1 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
9	NDC: 83254-500-22	2 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
10	NDC: 83254-500-55	5 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/04/2023	06/07/2024

Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)

Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)

Establishment
Name	Address	ID/FEI	Business Operations
1201258 Ontario Inc. O/A Nanz Pharma		256906595	manufacture(83254-500) , pack(83254-500) , label(83254-500)

Revised: 6/2024

Document Id: 1a4fbcb5-b984-f558-e063-6294a90a832c

34390-5

Set id: fadf9cac-5875-3440-e053-6394a90afda4

Version: 4

Effective Time: 20240607