FDA.reportPublic FDA data

Povidone-Iodine Swabstick

Manufacturer
Professional Disposables International, Inc.
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:46:01

Label at a glance#

ProductPovidone-Iodine Swabstick
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

For preparation of the skin prior to surgery Helps reduce bacteria that can potentially cause skin infection

Dosage and administration

For preparation of the skin prior to surgery clean the treatment area remove applicator by end of swabstick apply to the operative site prior to surgery allow to dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that can potentially cause skin infection

Warnings

WARNINGS SECTION

For external use only

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

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.

Directions

DOSAGE & ADMINISTRATION SECTION

For preparation of the skin prior to surgery

  • clean the treatment area
  • remove applicator by end of swabstick
  • apply to the operative site prior to surgery
  • allow to dry

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide

Do not use

OTC - DO NOT USE SECTION

Do not use

- in the eyes, nose or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

S41350 web NDC# 10819-3800-1

Web 1Web 1

S41350 box NDC# 10819-3800-1

carton 1carton 1

S41125 web NDC# 10819-3800-2

web 2web 2

S41125 box NDC# 10819-3800-2

carton 2carton 2

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00310819000185GTIN-14: 00310819000185
GTIN-12: 310819000185
UPC-A: 310819000185
EAN-13: 0310819000185
GTIN storage (14 digits): 00310819000185		SJK1251_PVP-US-3s-Web_PO443041_JL-aprvd_clean.jpg
BarcodeCode 128(01)10310819000175GTIN-14: 10310819000175
GTIN storage (14 digits): 10310819000175		S41350 140x100x138mm JKWPCB-2504250002_PVP-US-3s-Carton_PO443042_JL-aprvd_clean.jpg
BarcodeCode 128(01)10310819000182GTIN-14: 10310819000182
GTIN storage (14 digits): 10310819000182		S41125 195x80x146mm JKWPCB-2504250001_PVP-US-3s-Carton_PO443041_JL-aprvd_clean.jpg
Data codeData Matrix2NS413SJK1250-2_PVP-US-1s-Web_PO443042_JL-aprvd_clean.jpg
Data codeData Matrix2RS411SJK1251_PVP-US-3s-Web_PO443041_JL-aprvd_clean.jpg
Data codeData Matrix5LS41125S41125 195x80x146mm JKWPCB-2504250001_PVP-US-3s-Carton_PO443041_JL-aprvd_clean.jpg
Data codeData Matrix5MS41350S41350 140x100x138mm JKWPCB-2504250002_PVP-US-3s-Carton_PO443042_JL-aprvd_clean.jpg

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
10819-3800-1Povidone-Iodine Swabstick2.5 mL in 1 PACKETSTICK2.53
10819-3800-1Povidone-Iodine Swabstick50 in 1 BOXSTICK503
10819-3800-2Povidone-Iodine Swabstick7 mL in 1 PACKETSTICK73
10819-3800-2Povidone-Iodine Swabstick25 in 1 BOXSTICK253

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10819-380010819-3800-1, 10819-3800-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-10-06monthly-update2026-06-03 17:37:56
12025-05-15full-release2026-06-01 01:01:03

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 SwabstickPOVIDONE IODINEProfessional Disposables International, Inc.31d08e09-181b-3a7a-e063-6294a90aa7572026-02-17WarningsExact identifier
ndc (package): 10819-3800-1
ndc (package): 10819-3800-2
ndc (product): 10819-3800
ndc11 (package): 10819380001
ndc11 (package): 10819380002
spl id: 4b062bc1-2599-775d-e063-6294a90a4582
spl set id: 31d08e09-181b-3a7a-e063-6294a90aa757

Reported adverse events (FAERS/openFDA)#

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