FDA.reportPublic FDA data

Povidone Iodine Prep Pads

Manufacturer
Custom Kits Company Inc | Dynarex
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:59

Label at a glance#

ProductPovidone Iodine Prep Pads
Active ingredientPOVIDONE-IODINE
Label structure12 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 reduct bacteria that can potentially cause skin infection

Dosage and administration

Tear at notch Remove applicator Use only once As a first aid antiseptic - Clean affected area apply 1 to 3 times daily May be covered with a sterile bandage If bandaged let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

For preparation of the skin prior to surgery

Helps reduct 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 antiseptic for more than 1 week

Over large areas of the body

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

Deep or puncuture wounds

Animal bites

Serious wounds

Stop Use and ask doctor if

OTC - STOP USE SECTION

Condition worsens or persists for more than 72 hours

Irritation and rednes develops

Keep Out of the reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Tear at notch

Remove applicator

Use only once

As a first aid antiseptic - Clean affected area

apply 1 to 3 times daily

May be covered with a sterile bandage

If bandaged let dry first

OTHER SAFETY INFORMATION

Store at room temperature

Avoid excessive heat

Inactive ingredient

INACTIVE INGREDIENT SECTION

nonoxynol-9, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pvp.jpgpvp.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037205povidone-iodine 1 % Medicated PadPSN3
1037205povidone-iodine 10 MG/ML Medicated PadSCD3
1037205povidone-iodine 1 % Medicated PadSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68183-119-012022-01-28C16284748780-1d6a99b39-a029-a426-e053-dadaa90af4c2Povidone Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68183-119-01Povidone Iodine Prep Pads10 mL in 1 BOX, UNIT-DOSECLOTH103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68183-119POVIDONE IODINE PREP PADS CLOTH [CUSTOM KITS COMPANY INC]3Legacy NDC, 1 package rows20200118_222a1db3-d4b2-58ee-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68183-11968183-119-01

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
POVIDONE-IODINE85H0HZU99MACTIM
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii candidate
2 equally ranked IID candidates

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
7e02f6ee-8e03-6aa2-e053-2991aa0a8d97222a1db3-d4b2-58ee-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 7e02f6ee-8e03-6aa2-e053-2991aa0a8d97
spl set id: 222a1db3-d4b2-58ee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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