FDA.reportPublic FDA data

Antiseptic Povidone Iodine Prep Pad

Manufacturer
M-star (Hubei) Health&Care Products Co., Ltd.
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:30

Label at a glance#

ProductAntiseptic Povidone Iodine Prep Pad
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

Clean the treatment area Apply to the treatment area or operative site before surgery

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Providone-Iodine 10% w/w (1% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.

Warnings:

WARNINGS SECTION

  • For external use only 
  • Single use only

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use:

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • as a first aid antiseptic for longer than one week unless 
  • directed by a physician
  • on individuals who are sensitive or allergic to iodine
  • if package is damaged or open

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation,redness,or symptoms develops
  • if the condition persists or gets worse.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean the treatment area
  • Apply to the treatment area or operative site before surgery

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified water

Question?

OTC - QUESTIONS SECTION

+1(855)924-2182

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label00Label00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN1
797730povidone-iodine 100 MG/ML Medicated PadSCD1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY1
797730povidone-iodine 10 % Medicated PadSY1
797730povidone-iodine 10 % Medicated SwabstickSY1

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
84219-006-00Antiseptic Povidone Iodine Prep Pad0.45 g in 1 PATCHCLOTH0.451
84219-006-00Antiseptic Povidone Iodine Prep Pad1 in 1 POUCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-006ANTISEPTIC POVIDONE IODINE PREP PAD (POVIDONE-IODINE) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 2 package rows20240515_fc76c1f3-b48e-4276-890d-5b8e5a894e62.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84219-00684219-006-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
ndc (package): 84219-006-00
ndc (product): 84219-006
ndc11 (package): 84219000600
spl id: 1507ac3e-81e3-892c-e063-6394a90ac565
spl set id: fc76c1f3-b48e-4276-890d-5b8e5a894e62

Reported adverse events (FAERS/openFDA)#

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