FDA.reportPublic FDA data

PROVIDONE-IODINE PREP PADS

Manufacturer
A2Z Products, LLC
Effective date
2021-10-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:30:59

Label at a glance#

ProductPROVIDONE-IODINE PREP PADS
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes, and burns For preparation of the skin prior to surgery Helps reduce bacteria that can potentially cause skin infection

Dosage and administration

Tear a notch Remove applicator Use only once Clean affected area apply 1 to 3 times daily May be covered with sterile bandage If bandaged, let dry first Clean area Apply to operative site prior to surgery using applicator

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INTENDED USE OF THE DEVICE

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes, and burns

For preparation of the skin prior to surgery

Helps reduce bacteria that can potentially cause skin infection

Warnings

WARNINGS SECTION

For External Use Only.

Do not use

OTC - DO NOT USE SECTION

In the eyes

As a first aid anticeptic for more than 1 week

Over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Deep puncture wounds

Animal bites

Serious wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or persists for more than 72 hours

Irritation and redness develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

INSTRUCTIONS FOR USE SECTION

Tear a notch

Remove applicator

Use only once

As a first aid antiseptic

INSTRUCTIONS FOR USE SECTION

Clean affected area

apply 1 to 3 times daily

May be covered with sterile bandage

If bandaged, let dry first

For preoperative patient skin preparation

INSTRUCTIONS FOR USE SECTION

Clean area

Apply to operative site prior to surgery using applicator

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Nonoxynol-9, water

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Sterile unless poch is opened or damaged.

Saturated with 10% Povidone Iodine.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

For External Use Only. Apply topically as needed. Discard after single use.

Povidone-Iodine Prep Pads - 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone Iodine Prep Pads - 100Povidone Iodine Prep Pads - 100

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72728-00172728-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
NONOXYNOL-948Q180SH9TIACT
POVIDONE-IODINE85H0HZU99MACTIM

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
cef77a2d-e963-fb7d-e053-2995a90a12db816b8feb-c4f0-01ce-e053-2a91aa0aee782021-10-22WarningsExact identifier
spl id: cef77a2d-e963-fb7d-e053-2995a90a12db
spl set id: 816b8feb-c4f0-01ce-e053-2a91aa0aee78

Reported adverse events (FAERS/openFDA)#

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