Leader Povidone-Iodine 10% Topical Solution

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Leader Povidone-Iodine 10% Topical Solution
Generic name: POVIDONE IODINE PREP SOLUTION 10%
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: b023e2e3-a4af-eb19-e053-2995a90a7c6e
SPL ID: 4470e703-0b71-de82-e063-6394a90a6736
Version: 6
Effective date: 2025-11-25
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:38:17

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Leader Povidone-Iodine 10% Topical Solution	openfda.brand_name
generic name		POVIDONE IODINE PREP SOLUTION 10%	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0060-1	openfda.package_ndc
ndc	product	70000-0060	openfda.product_ndc
ndc11	package	70000006001	derived:openfda.package_ndc
rxcui		312564	openfda.rxcui
spl id		4470e703-0b71-de82-e063-6394a90a6736	id
spl set id		b023e2e3-a4af-eb19-e053-2995a90a7c6e	set_id
unii		85H0HZU99M	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do Not Use if allergic to iodine in the eyes Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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