FDA.reportPublic FDA data

Henry Schein Povidone-Iodine Swabsticks

Manufacturer
Henry Schein, Inc.
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:45

Label at a glance#

ProductHenry Schein Povidone-Iodine Swabsticks
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

Apply product to skin as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

OTC - ASK DOCTOR SECTION

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burn

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • infection occurs
  • redness, irritation or swelling develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply product to skin as needed

Other information

OTHER SAFETY INFORMATION

  • 1 % titratable iodine
  • Avoid excessive heat
  • Store at room temperature
  • For hospital or professional use only
  • Not made with natural rubber latex

Inactive ingredients

INACTIVE INGREDIENT SECTION

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Questions?

OTC - QUESTIONS SECTION

1-800-472-4346

Principal Display Panel - 1.8 mL Item Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0404-0120-03

HENRY SCHEIN ®

REF 570-1548

POVIDONE-IODINE
SWABSTICKS

10% Povidone-Iodine

Triple Packs

HENRY SCHEIN
SEAL OF EXCELLENCE ®

Principal Display Panel - 1.8 mL Item Label
Principal Display Panel - 1.8 mL Item Label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0120-03Henry Schein Povidone-Iodine Swabsticks3 in 1 POUCHSWAB33
0404-0120-03Henry Schein Povidone-Iodine Swabsticks500 in 1 CASESWAB5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0120HENRY SCHEIN POVIDONE-IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [HENRY SCHEIN, INC.]3Current NDC, Legacy NDC, 2 package rows20231014_5854f241-6cfc-4e5a-ba72-92dd0703f728.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-01200404-0120-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
NONOXYNOL-10K7O76887APIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POTASSIUM IODIDE1C4QK22F9JIACT
POVIDONE-IODINE85H0HZU99MACTIM

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
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
ndc (package): 0404-0120-03
ndc (product): 0404-0120
ndc11 (package): 00404012003
spl id: 07a02b63-fcac-97c6-e063-6294a90a0351
spl set id: 5854f241-6cfc-4e5a-ba72-92dd0703f728

Reported adverse events (FAERS/openFDA)#

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