POVIDONE IODINE- povinanz ointment 10% ointment 
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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Povinanz Ointment 10%

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

Label for all povidone iodine 10 percentLabel for all povidone iodine 10 percent

POVIDONE IODINE 
povinanz ointment 10% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83254-001-50150 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
2NDC:83254-001-10100 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
3NDC:83254-001-9090 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
4NDC:83254-001-6060 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
5NDC:83254-001-3030 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
6NDC:83254-001-0110 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
7NDC:83254-001-1515 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
8NDC:83254-001-055 g in 1 TUBE; Type 0: Not a Combination Product05/04/2023
9NDC:83254-001-311 g in 1 POUCH; Type 0: Not a Combination Product05/04/2023
10NDC:83254-001-212 g in 1 POUCH; Type 0: Not a Combination Product05/04/2023
11NDC:83254-001-555 g in 1 POUCH; Type 0: Not a Combination Product05/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00505/04/2023
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 Pharma256906595manufacture(83254-001) , label(83254-001) , pack(83254-001)

Revised: 5/2023
Document Id: fbfb0179-91a3-c830-e053-6294a90abfdb
Set id: fae1b57d-f6fb-cc93-e053-6394a90a2d2d
Version: 4
Effective Time: 20230518
 
1201258 Ontario Inc. O/A Nanz Pharma