Povidone-Iodine Prep Sterile

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: Povidone-Iodine Prep Sterile
Generic name: POVIDONE-IODINE
Manufacturer: Cardinal Health 200 LLC
Product type: HUMAN OTC DRUG
SPL set ID: 6f5ac6b5-389d-473b-8398-176e48adc1b5
SPL ID: 09c732f6-0bf8-b95e-e063-6394a90aa53b
Version: 3
Effective date: 2023-11-10
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:43

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		505G(a)(3)	openfda.application_number
brand name		Povidone-Iodine Prep Sterile	openfda.brand_name
generic name		POVIDONE-IODINE	openfda.generic_name
manufacturer name		Cardinal Health 200 LLC	openfda.manufacturer_name
ndc	package	63517-254-21	openfda.package_ndc
ndc	product	63517-254	openfda.product_ndc
ndc11	package	63517025421	derived:openfda.package_ndc
rxcui		797730	openfda.rxcui
spl id		09c732f6-0bf8-b95e-e063-6394a90aa53b	id
spl set id		6f5ac6b5-389d-473b-8398-176e48adc1b5	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 apply to persons allergic to iodine Do not use • in the eyes Ask a doctor before use if injuries are • deep wounds • puncture wounds • serious burns Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours • infection occurs Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation. Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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