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: Changzhou Maokang Medical Products Co., Ltd
Product type: HUMAN OTC DRUG
SPL set ID: bb62784a-d7b7-471e-9aed-0c6d2e349c3a
SPL ID: 0c6746b7-c400-05e3-e063-6394a90a9d80
Version: 4
Effective date: 2023-12-13
Source export date: 2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:13:38

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 · 10 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		Changzhou Maokang Medical Products Co., Ltd	openfda.manufacturer_name
ndc	package	59050-658-11	openfda.package_ndc
ndc	product	59050-658	openfda.product_ndc
ndc11	package	59050065811	derived:openfda.package_ndc
spl id		0c6746b7-c400-05e3-e063-6394a90a9d80	id
spl set id		bb62784a-d7b7-471e-9aed-0c6d2e349c3a	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.