FDA.reportPublic FDA data

Prep non sterile

Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:17

Label at a glance#

ProductPrep non sterile
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-lodine 10%w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For preparation of the skin prior to surgery

Warnings

WARNINGS SECTION

For external use only.

Do not apply to persions allergic to iodine.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

injuries are deep wounds, puncture wounds, serious burns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Driections

DOSAGE & ADMINISTRATION SECTION

Clean area. Apply to the operative site prior to surgery

Other information

SPL UNCLASSIFIED SECTION

1% titratable iodine. Store at ambient temperatures.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purifed water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label011Label011

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
59050-455-10Prep non sterile5.5 g in 1 POUCHPATCH5.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-455PREP NON STERILE (POVIDONE-IODINE) PATCH [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, Legacy NDC, 1 package rows20231116_ecbe037b-77da-4ffc-8c60-e56f428766af.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
59050-45559050-455-10

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
NONOXYNOL-10K7O76887APIACT
POTASSIUM IODIDE1C4QK22F9JIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Prep non sterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdecbe037b-77da-4ffc-8c60-e56f428766af2023-11-15WarningsExact identifier
ndc (package): 59050-455-10
ndc (product): 59050-455
ndc11 (package): 59050045510
spl id: 0a3e519c-ecd6-d487-e063-6294a90a1f47
spl set id: ecbe037b-77da-4ffc-8c60-e56f428766af

Reported adverse events (FAERS/openFDA)#

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