FDA.reportPublic FDA data

Povidone-Iodine

Manufacturer
Mazza Healthcare, LLC
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:40

Label at a glance#

ProductPovidone-Iodine
Active ingredientPovidone-Iodine
Label structure9 sections

Dosage and administration

clean the affected area apply product on the area 1-3 times daily may be covered with a sterile bandage when dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, USP, 10% v/v
(equivalent to 1% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • over large areas of the body
  • as first aid antiseptic longer than 1 week unless directed by doctor

Discontinue use if irritation and redness develop.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

OTC - STOP USE SECTION

Stop use and consult a doctor if the condition persists or gets worse.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply product on the area 1-3 times daily
  • may be covered with a sterile bandage when dry

Other information

OTHER SAFETY INFORMATION

Store at room temperature 59-86ºF (15-30ºC).

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

Mazza Healthcare, LLC
1-877-629-9242

Principal Display Panel - 2000 Pouch Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MH

Mazza Healthcare

MODEL NO.: 02-050-00

DESCRIPTION: POVIDONE-IODINE PREP PADS, MEDIUM
NON-STERILE

QUANTITY: 1 CASE (2000 EACH)

LOT NO.:

MANUFACTURE DATE:

EXPIRY DATE:

MANUFACTURED FOR:

Mazza Healthcare, LLC

Bannockburn, IL 60015 • USA

MADE IN CHINA

NDC 81280-002-01

Principal Display Panel - 2000 Pouch Carton Label
Principal Display Panel - 2000 Pouch Carton Label

Principal Display Panel - 1 Prep Pad Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MH

Mazza Healthcare

Povidone-Iodine
Prep Pad

NDC 81280-002-01

Antiseptic • Germicide

Medium • 2-Ply

Non-Sterile • Single Use Only

Reorder No. 02-050-00

Principal Display Panel - 1 Prep Pad Pouch Label
Principal Display Panel - 1 Prep Pad Pouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037205povidone-iodine 1 % Medicated PadPSN2
1037205povidone-iodine 10 MG/ML Medicated PadSCD2
1037205povidone-iodine 1 % Medicated PadSY2

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
81280-002-01Povidone-Iodine1 in 1 POUCHSWAB12
81280-002-01Povidone-Iodine2000 in 1 CARTONSWAB20002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81280-002POVIDONE-IODINE SWAB [MAZZA HEALTHCARE, LLC]2Current NDC, Legacy NDC, 2 package rows20241123_3dc3303f-54b2-4aec-8568-5e0f8eb7cb14.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81280-00281280-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Povidone-Iodine85H0HZU99MACTIM
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Nonoxynol-10K7O76887APIACT
Water059QF0KO0RIACT
Sodium Hydroxide55X04QC32IIACT

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-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
ndc (package): 81280-002-01
ndc (product): 81280-002
ndc11 (package): 81280000201
spl id: 9302db32-d3ac-48cd-88ba-f6ea3c02888d
spl set id: 3dc3303f-54b2-4aec-8568-5e0f8eb7cb14

Reported adverse events (FAERS/openFDA)#

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