FDA.reportPublic FDA data

POVIDONE-IODINE PAD- povidone-iodine swab

Manufacturer
Raya Pharmaceuticals LLC
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:58:22

Label at a glance#

ProductPOVIDONE-IODINE PAD- povidone-iodine swab
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

SWABSWABAntiseptic for preparation of the skin.

For external use only.

Apply locally as needed.

PRECAUTIONS SECTION

For external use only.

WARNINGS AND PRECAUTIONS SECTION

For external use only.

Discontinue use if irritation and redness develop.

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at room temperature

DOSAGE & ADMINISTRATION SECTION

Apply Localy As Needed

WARNINGS SECTION

For External Use Only

Discontinue use if Irretation and reddness appear

Keep Out of Reach of Children

INACTIVE INGREDIENT SECTION

Water is added as inactive ingredient

OTC - ACTIVE INGREDIENT SECTION

POVIDONE-IODINE 10% W/W(equivelent to iodine 1%)

OTC - PURPOSE SECTION

POVIDONE-IODINE 10% W/W(equivelent to iodine 1%)................. Purpose: Antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of reach of Children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:82098-0617-10

POVIDONE-IODINE PAD

10% POVIDONE-IODINE

Single USE Only

Principal Display ImagePrincipal Display Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN5
797730povidone-iodine 100 MG/ML Medicated PadSCD5
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY5
797730povidone-iodine 10 % Medicated PadSY5
797730povidone-iodine 10 % Medicated SwabstickSY5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82098-617-10POVIDONE-IODINE PAD- povidone-iodine swab0.6 g in 1 POUCHSWAB0.65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82098-617POVIDONE-IODINE PAD- POVIDONE-IODINE SWAB (POVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)) SWAB [RAYA PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20231030_dbcbd1be-5274-3de3-e053-2995a90abf1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82098-617-10EA - Each82098-617b1b42dea-0137-48fe-a2d9-e92b5110044212023-02-06

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
82098-61782098-617-10

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
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
ndc (package): 82098-617-10
ndc (product): 82098-617
ndc11 (package): 82098061710
spl id: 08b47e2f-3919-c3ff-e063-6294a90a537b
spl set id: dbcbd1be-5274-3de3-e053-2995a90abf1c

Reported adverse events (FAERS/openFDA)#

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