FDA.reportPublic FDA data

Povidone-Iodine Prep

Manufacturer
Genuine First Aid, LLC
Effective date
2011-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:27:39

Label at a glance#

ProductPovidone-Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Indications and uses

Provides, antiseptic germicidal skin preperation for minor invasive procedures

Dosage and administration

Clean intended area thoroughly with pad. Discard after single use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

One Prep pad saturated with a 10% Povidone-Iodine solution equivalent to 1% available iodine

Purpose

OTC - PURPOSE SECTION

antiseptic, germicidal

Uses

INDICATIONS & USAGE SECTION

Provides, antiseptic germicidal skin preperation for minor invasive procedures

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For external use only.

Caution

WARNINGS SECTION

In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean intended area thoroughly with pad. Discard after single use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Antiseptic
Povidone-Iodine
Prep Pads
 medium
Saturated with a 10% Povidone-Iodine
Solution equavalent to 1% available iodine

GFA Production Xiamen Co., Ltd.
www.gfaproduction.com

GFA Production Xiamen Co., Ltd.
No. 20 Huli Industrial Park, Meixi Road,
Tong'an, Xiamen, Fujian, China 361100

Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street
LONDON W1G 9QR, England, United Kingdom

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone-Iodine Prep PadsPovidone-Iodine Prep Pads

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone-Iodine Prep PadsPovidone-Iodine Prep Pads

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone-Iodine Prep PadsPovidone-Iodine Prep Pads

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN2
797730povidone-iodine 100 MG/ML Medicated PadSCD2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY2
797730povidone-iodine 10 % Medicated PadSY2
797730povidone-iodine 10 % Medicated SwabstickSY2

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
52124-2901-02019-10-29C16284748780-1960f7f55-c548-8e05-e053-dbdaa90a074aPovidone-Iodine Prep Pads
52124-2901-12019-10-29C16284748780-1960f7f55-c548-8e05-e053-dbdaa90a074aPovidone-Iodine Prep Pads
52124-2901-22019-10-29C16284748780-1960f7f55-c548-8e05-e053-dbdaa90a074aPovidone-Iodine Prep Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52124-2901-0Povidone-Iodine Prep0.5 mL in 1 PACKETSWAB0.52
52124-2901-1Povidone-Iodine Prep10 in 1 BOXSWAB102
52124-2901-1Povidone-Iodine Prep0.5 mL in 1 PACKETSWAB0.52
52124-2901-2Povidone-Iodine Prep0.5 mL in 1 PACKETSWAB0.52
52124-2901-2Povidone-Iodine Prep100 in 1 BOXSWAB1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52124-2901POVIDONE-IODINE PREP (POVIDONE-IODINE) SWAB [GENUINE FIRST AID, LLC]2Legacy NDC, 5 package rows20110406_7a7fd888-103e-4948-a220-f28df56361ac.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
IODINEACTIVE MOIETY9679TC07X42
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52124-290152124-2901-0, 52124-2901-1, 52124-2901-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT

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
832bed96-a18f-47af-8b24-848a267eee5b7a7fd888-103e-4948-a220-f28df56361ac2011-04-05WarningsExact identifier
spl id: 832bed96-a18f-47af-8b24-848a267eee5b
spl set id: 7a7fd888-103e-4948-a220-f28df56361ac

Reported adverse events (FAERS/openFDA)#

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