POVIDONE IODINE- povinanz ointment 10% ointment

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]

Purpose:

Topical Antifungal

Active Ingredients

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 of 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 use 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.

Inactive Ingredients

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400

Questions

Nanz Pharma

575 Granite Ct.

Pickering, ON

L1W 3K1

Directions

Apply a 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 change 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.

Storage:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povinanz ointment 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 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: 83254-001-50	150 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
2	NDC: 83254-001-10	100 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
3	NDC: 83254-001-90	90 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
4	NDC: 83254-001-60	60 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
5	NDC: 83254-001-30	30 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
6	NDC: 83254-001-01	10 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
7	NDC: 83254-001-15	15 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
8	NDC: 83254-001-05	5 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2023
9	NDC: 83254-001-31	1 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
10	NDC: 83254-001-21	2 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
11	NDC: 83254-001-55	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 final	M005	05/04/2023

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(83254-001) , label(83254-001) , pack(83254-001)