POVIDONE IODINE- povidone iodine 7.5 solution solution

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:

7.5% Povidone Iodine Solution USP, (0.75% available Iodine)

Uses:

For the treatment of athlete's foot, jock itch, and ringworm

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:

Anydrous dibasic sodium phosphate, Citric acid monohydrate, Glycerin, Polyethylene glycol 1500, Nonoxynol-3, Potassium iodate, Water

Questions?

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 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 
povidone iodine 7.5 solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM IODATE (UNII: I139E44NHL)
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-705-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
2	NDC: 83254-705-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
3	NDC: 83254-705-25	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
4	NDC: 83254-705-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
5	NDC: 83254-705-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
6	NDC: 83254-705-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
7	NDC: 83254-705-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
8	NDC: 83254-705-90	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
9	NDC: 83254-705-18	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
10	NDC: 83254-705-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
11	NDC: 83254-705-20	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2023
12	NDC: 83254-705-11	30 mL in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
13	NDC: 83254-705-22	60 mL in 1 POUCH; Type 0: Not a Combination Product	05/04/2023
14	NDC: 83254-705-33	90 mL 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(83254-705) , pack(83254-705) , label(83254-705)