FDA.reportPublic FDA data

Povinanz 5% Antiseptic Solution

Manufacturer
1201258 Ontario Inc. O/A Nanz Pharma
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:30:23

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 5%

0.5% available iodine

Purpose:

OTC - PURPOSE SECTION

Topical Antiseptic

Warnings:

WARNINGS SECTION

For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and ask a doctor if the condition persists or gets worse. Stop use and ask doctor if redness, irritation, swelling, or pain persists, and infection occurs. Do not use longer than 1 week unless directed by a doctor. Do not use if allergic to iodine, in the eyes. Avoid pooling beneath the patient. Avoid excessive heat. Store at room temperature.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

Use:

INDICATIONS & USAGE SECTION

Antiseptic skin preparation

Other information

OTHER SAFETY INFORMATION

- not made with natural rubber latex

- for hospital and professional use only.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

InAnhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-9, potassium iodate, water

Questions:

OTC - QUESTIONS SECTION

Nanz Pharma Inc., 575 Granite Court, Pickering, ON, L1W 3K1, Canada

Label for 5% solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for all povidone iodine 5 percentLabel for all povidone iodine 5 percentLabel for all povidone iodine 5 percentLabel for all povidone iodine 5 percent

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83254-10583254-105-02, 83254-105-05, 83254-105-25, 83254-105-01, 83254-105-15, 83254-105-10, 83254-105-50, 83254-105-60, 83254-105-90, 83254-105-20, 83254-105-18, 83254-105-11, 83254-105-22, 83254-105-66

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM IODATEI139E44NHLIACT
NONOXYNOL-948Q180SH9TIACT
GLYCERINPDC6A3C0OXIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a4f896f-7144-669d-e063-6394a90af469fd9f7bc0-bd91-2ca1-e053-6394a90a99882024-06-07WarningsExact identifier
spl set id: fd9f7bc0-bd91-2ca1-e053-6394a90a9988

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.