FDA.reportPublic FDA data

Povidone-Iodine Gel Swabstick Non-Sterile

Manufacturer
Changzhou Maokang Medical Products Co. Ltd
Effective date
2019-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:43

Label at a glance#

ProductPovidone-Iodine Gel Swabstick Non-Sterile
Active ingredientPOVIDONE-IODINE
Label structure7 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

Antiseptic skin preparation

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if allergic to Iodine
  • in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rednes, irritation, swelling or pain persists or increases
  • infection occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid pooling beneath the patient

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep puncture wounds
  • serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

apply product to skin as needed

Other Information

SPL UNCLASSIFIED SECTION

  • 1% titratable
  • for hospital or professional use only

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

MK Povidone-Iodine Gel Swabstick

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itemitem

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
59050-250-102023-01-30C16284748780-1f386c649-fedc-0266-e053-dadaa90a7c1aMK Povidone- Iodine Gel Swabstick Non-Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59050-250-10Povidone-Iodine Gel Swabstick Non-Sterile2.3 g in 1 POUCHGEL2.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-250POVIDONE-IODINE GEL SWABSTICK NON-STERILE (POVIDONE IODINE) GEL [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO. LTD]2Legacy NDC, 1 package rows20191203_969b0064-fb05-a1e0-e053-2995a90a6468.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
59050-25059050-250-10

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
POVIDONE-IODINE85H0HZU99MACTIM
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
NONOXYNOL-10K7O76887APIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)X70SE62ZARIACT
POTASSIUM IODIDE1C4QK22F9JIACT
GLYCERINPDC6A3C0OXIACT

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
98bf82b7-b52e-2fc6-e053-2a95a90a4a06969b0064-fb05-a1e0-e053-2995a90a64682019-12-02WarningsExact identifier
spl id: 98bf82b7-b52e-2fc6-e053-2a95a90a4a06
spl set id: 969b0064-fb05-a1e0-e053-2995a90a6468

Reported adverse events (FAERS/openFDA)#

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