FDA.reportPublic FDA data

Maokang Povidone-Iodine Gel

Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:22

Label at a glance#

ProductMaokang Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic 

Use

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Patient preoparative skin preparation

Warnings

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • deep wounds
  • puncture wounds
  • serious burns

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label.jpgOuter Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN2
312564povidone-iodine 100 MG/ML Topical SolutionSCD2
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY2

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
59050-802-00Maokang Povidone Iodine29.5 mL in 1 POUCHLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-802MAOKANG POVIDONE IODINE (POVIDONE-IODINE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]2Current NDC, 1 package rows20240628_b3b885b6-5278-491f-ae75-8b7032fcccd8.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
59050-80259050-802-00

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
NONOXYNOL-10K7O76887APIACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
Maokang Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdb3b885b6-5278-491f-ae75-8b7032fcccd82024-06-26WarningsExact identifier
ndc (package): 59050-802-00
ndc (product): 59050-802
ndc11 (package): 59050080200
spl id: 1bce5458-b7df-c06a-e063-6394a90a381b
spl set id: b3b885b6-5278-491f-ae75-8b7032fcccd8

Reported adverse events (FAERS/openFDA)#

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