FDA.reportPublic FDA data

TWO PVP-I SCRUB LARGE WINGED SPONGES

Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:50

Label at a glance#

ProductTWO PVP-I SCRUB LARGE WINGED SPONGES
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

use sponge sticks to prep desired area

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10%w/w

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

  • Do not apply to persons allergic to iodine

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep wounds
  • puncture wounds
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness, irritation, swelling or pain persists or increases
  • infection occurs
  • Prolonged exposure to wet solution may cause skin irritation.
  • Store at room temperature. 

Avoid pooling beneath the patient.

Avoid excessive heat.

For external use only

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use sponge sticks to prep desired area

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, anhydrous citric acid, Sodium dodecyl sulfate, purifed water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.17Label.17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59050-754-12TWO PVP-I SCRUB LARGE WINGED SPONGES10 in 1 BOXSPONGE103
59050-754-12TWO PVP-I SCRUB LARGE WINGED SPONGES2 in 1 POUCHSPONGE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-754TWO PVP-I SCRUB LARGE WINGED SPONGES (POVIDONE-IODINE) SPONGE [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231111_4295c0c5-6be0-4d0f-9456-a92e3571d679.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
59050-75459050-754-12

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
NONOXYNOL-10K7O76887APIACT
POTASSIUM IODIDE1C4QK22F9JIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
TWO PVP-I SCRUB LARGE WINGED SPONGESPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd4295c0c5-6be0-4d0f-9456-a92e3571d6792023-11-10WarningsExact identifier
ndc (package): 59050-754-12
ndc (product): 59050-754
ndc11 (package): 59050075412
spl id: 09c713eb-f407-4842-e063-6294a90a1760
spl set id: 4295c0c5-6be0-4d0f-9456-a92e3571d679

Reported adverse events (FAERS/openFDA)#

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