Povidone Iodine Prep Solution 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 Solution Sterile
Generic name: POVIDONE-IODINE
Manufacturer: Jianerkang Medical Co., Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 95f8489e-05fa-4f0f-acd6-0c426009080e
SPL ID: 085d0195-7031-e123-e063-6294a90ab344
Version: 3
Effective date: 2023-10-23
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:12

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 Solution Sterile	openfda.brand_name
generic name		POVIDONE-IODINE	openfda.generic_name
manufacturer name		Jianerkang Medical Co., Ltd	openfda.manufacturer_name
ndc	package	34645-0013-1	openfda.package_ndc
ndc	product	34645-0013	openfda.product_ndc
ndc11	package	34645001301	derived:openfda.package_ndc
rxcui		312564	openfda.rxcui
spl id		085d0195-7031-e123-e063-6294a90ab344	id
spl set id		95f8489e-05fa-4f0f-acd6-0c426009080e	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 Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if infection occurs redness, irritation, swelling or pain persists or increases Store at room temperature. Avoid pooling beneath patient Avoid excessive heat. Keep out of reach of children. In case of accidental ingestion, seek professinoal assistance or consult a poion control center immediately

Reported adverse events (FAERS/openFDA)#

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