FDA.reportPublic FDA data

Povidone-Iodine Solution Sterile

Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:19

Label at a glance#

ProductPovidone-Iodine Solution 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 10%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

for antiseptic skin preparation

Warnings

WARNINGS SECTION

do not use

OTC - DO NOT USE SECTION

  • if allergic to Iodine
  • do not use in the eye

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reavh 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 patient.

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep or punture wounds
  • serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

Apply product to skin as needed.

Other information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • for hospital or professional use only

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Alkyl glucoside,citric acid,glycerin, hydroxyethyl cellulose,nonoxynol-10, potassium iodide, purified water, hydroxode

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9Label9

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN4
312564povidone-iodine 100 MG/ML Topical SolutionSCD4
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY4

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
59050-554-11Povidone-Iodine Solution Sterile30 mL in 1 POUCHLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-554POVIDONE-IODINE SOLUTION STERILE (POVIDONE-IODINE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, Legacy NDC, 1 package rows20241122_478e9d3c-42ff-4ccc-8dd8-6f690cd629d7.zip

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
59050-55459050-554-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
NONOXYNOL-10K7O76887APIACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
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
Povidone-Iodine Solution SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd478e9d3c-42ff-4ccc-8dd8-6f690cd629d72024-11-21WarningsExact identifier
ndc (package): 59050-554-11
ndc (product): 59050-554
ndc11 (package): 59050055411
spl id: 276b2979-693b-5726-e063-6394a90a7c65
spl set id: 478e9d3c-42ff-4ccc-8dd8-6f690cd629d7

Reported adverse events (FAERS/openFDA)#

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