NANZ POVIDONE IODINE 10% SOLUTION- povidone iodine 10% solution liquid

Nanz Povidone Iodine 10% Solution by

Drug Labeling and Warnings

Nanz Povidone Iodine 10% Solution 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

10% Povidone Iodine Solution USP, (1% 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

DOSAGE & ADMINISTRATION

Use as directed.

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

Note: Change non-active ingredient from nonoxynol-3 to nonoxynol-9

INGREDIENTS AND APPEARANCE

NANZ POVIDONE IODINE 10% SOLUTION 
povidone iodine 10% solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-010
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-010-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
2	NDC: 83254-010-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
3	NDC: 83254-010-25	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
4	NDC: 83254-010-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
5	NDC: 83254-010-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
6	NDC: 83254-010-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
7	NDC: 83254-010-50	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
8	NDC: 83254-010-90	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
9	NDC: 83254-010-18	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
10	NDC: 83254-010-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2023
11	NDC: 83254-010-20	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2023
12	NDC: 83254-010-11	30 mL in 1 POUCH; Type 0: Not a Combination Product	02/08/2023
13	NDC: 83254-010-22	60 mL in 1 POUCH; Type 0: Not a Combination Product	02/08/2023
14	NDC: 83254-010-33	90 mL in 1 POUCH; Type 0: Not a Combination Product	02/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M005	02/08/2023

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(83254-010) , label(83254-010) , pack(83254-010)