FDA.reportPublic FDA data

Povidone-Iodine 10% Solution

Manufacturer
Gabar Health Sciences Corp.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:35

Label at a glance#

ProductPovidone-Iodine 10% Solution
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Dosage and administration

Clean the area. Apply product to the operative site prior to surgery.

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​POVIDONE IODINE 10%

Warnings

WARNINGS SECTION

For external use only

​Do Not Use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

​Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children. ​ If swallowed, get medical help, or contact a Posion Control Center (1-800-222-1222) right away.

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Povidone-iodine 10%

​Purpose

OTC - PURPOSE SECTION

Healthcare Antiseptic

​Use

INDICATIONS & USAGE SECTION

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

​Use

OTC - WHEN USING SECTION

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

​Directions

DOSAGE & ADMINISTRATION SECTION

Clean the area. Apply product to the operative site prior to surgery.

Other

STORAGE AND HANDLING SECTION

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

​Questions?

SPL UNCLASSIFIED SECTION

1-470-737-9424

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​NDC 82429-202-16

Gabar Health Sciences

Povidone-Iodine

10% Solution

Topical Antiseptic

​1 Gallon (3.78 L)

Povidone-Iodine LabelPovidone-Iodine Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82429-202POVIDONE-IODINE 10% SOLUTION (POVIDONE IODINE 10% LIQUID) LIQUID [GABAR HEALTH SCIENCES CORP.]3Legacy NDC20231022_cc8d7fee-dcfe-4d36-844a-402f08375563.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82429-202-16ML - Milliliter82429-20285e7b0aa-6ee8-4b91-9a87-8a1e11edd86d12022-11-07

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
82429-20282429-202-16

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
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
4c2e0765-8140-6e06-e063-6394a90a0708cc8d7fee-dcfe-4d36-844a-402f083755632026-03-04WarningsExact identifier
spl set id: cc8d7fee-dcfe-4d36-844a-402f08375563

Reported adverse events (FAERS/openFDA)#

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