FDA.reportPublic FDA data

GNP Povidone Iodine

Manufacturer
Amerisource Bergen | Pharma Nobis, LLC
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-06-11 05:10:21

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

Clean the affected area Apply a small amount of this product to the area 1-3 times daily May be covered with a sterile bandage If bandaged, let dry first

Storage and handling

Store at room temperature: 15° - 30° C (59° - 86° F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

Discontinue use and ask a doctor

OTC - STOP USE SECTION

  • if condition persists or gets worse
  • for use longer than 1 week

Ask a doctor in case of

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount of this product to the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature: 15° - 30° C (59° - 86° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

citric acid

dibasic sodium phosphate

nonoxynol-9

glycerin

purified water

sofium hydroxide

RECENT MAJOR CHANGES SECTION

Updated to match new label.

LABEL INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNP Povidone.jpgGNP Povidone.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130087701408960GTIN-13: 0087701408960
EAN-13: 0087701408960
GTIN-12: 087701408960
UPC-A: 087701408960
GTIN storage (14 digits): 00087701408960		GNP Povidone.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-053-552020-03-17C16284748780-1956f9ecf-ce5b-621f-e053-dbdaa90a74adGNP Povidone Iodine
24385-053-552019-10-21C16284748780-1956f9ecf-ce5b-621f-e053-dbdaa90a74adGNP Povidone Iodine

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-053-55ML - Milliliter24385-05334e4bcb9-fdcf-48f3-974a-359e2d1c0c8012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
povidone-iodineACTIVE INGREDIENT85H0HZU99M2
povidone-iodineACTIVE MOIETY85H0HZU99M2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24385-05324385-053-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
NONOXYNOL-948Q180SH9TIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
ndc (package): 24385-053-55
ndc (product): 24385-053
ndc11 (package): 24385005355
spl id: 5370a9db-deae-fad0-e063-6394a90a616b
spl set id: f69a5cec-04f2-4028-94c6-1f129d2de5a9

Reported adverse events (FAERS/openFDA)#

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