FDA.reportPublic FDA data

Povidone-Iodine Prep Sterile

Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:15

Label at a glance#

ProductPovidone-Iodine Prep Sterile
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For preparation prior to surgery 
  • Helps to reduce bacteria that can potentially cause skin infection.

Warnings

WARNINGS SECTION

For external use only.

Do not apply to persons 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• irritation and redness develop 

• condition persists for more than 72 hours • infection occurs

Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Other information

SPL UNCLASSIFIED SECTION

• 1% titratable iodine • latex free • 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

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
59050-658-11Povidone-Iodine Prep Sterile2 in 1 POUCHSPONGE24
59050-658-11Povidone-Iodine Prep Sterile10 in 1 BOXSPONGE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-658POVIDONE-IODINE PREP STERILE (POVIDONE-IODINE) SPONGE [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, 2 package rows20231214_bb62784a-d7b7-471e-9aed-0c6d2e349c3a.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
59050-65859050-658-11

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
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 Prep SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdbb62784a-d7b7-471e-9aed-0c6d2e349c3a2023-12-13WarningsExact identifier
ndc (package): 59050-658-11
ndc (product): 59050-658
ndc11 (package): 59050065811
spl id: 0c6746b7-c400-05e3-e063-6394a90a9d80
spl set id: bb62784a-d7b7-471e-9aed-0c6d2e349c3a

Reported adverse events (FAERS/openFDA)#

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