FDA.reportPublic FDA data

Povidone-iodine prep pad

Manufacturer
JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:40

Label at a glance#

ProductPovidone-iodine prep pad
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Dosage and administration

Open packet and use as a washcloth.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP, 10% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

CAUTION: Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Use

INDICATIONS & USAGE SECTION

Antiseptic for preparation of the skin.

WARNINGS

WARNINGS SECTION

For external use only.

Discontinue use if irritation and redness develop.

Directions

DOSAGE & ADMINISTRATION SECTION

Open packet and use as a washcloth.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Ctric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

DRUG FACTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-1 povidone-Iodine prep padlabel-1 povidone-Iodine prep pad

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN3
797730povidone-iodine 100 MG/ML Medicated PadSCD3
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY3
797730povidone-iodine 10 % Medicated PadSY3
797730povidone-iodine 10 % Medicated SwabstickSY3

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
80514-002-012025-01-30C16284748780-12cef2736-8c53-d83d-e063-dadaa90ab31fae606094-7085-2247-e053-2a95a90afc9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80514-002-01Povidone-iodine prep pad0.5 g in 1 POUCHSWAB0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80514-002POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.]3Legacy NDC, 1 package rows20231226_ae606094-7085-2247-e053-2a95a90afc9d.zip

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
80514-00280514-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POTASSIUM IODIDE1C4QK22F9JIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM
NONOXYNOL-10K7O76887APIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT

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
0d63964f-9212-6ba7-e063-6294a90ad835ae606094-7085-2247-e053-2a95a90afc9d2023-12-26WarningsExact identifier
spl id: 0d63964f-9212-6ba7-e063-6294a90ad835
spl set id: ae606094-7085-2247-e053-2a95a90afc9d

Reported adverse events (FAERS/openFDA)#

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