Aplicare Povidone-Iodine

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: Aplicare Povidone-Iodine
Generic name: POVIDONE-IODINE
Manufacturer: Aplicare Products, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 1ad9237e-80ee-4769-ba53-9bc1bb667249
SPL ID: 4640c80b-048c-1a17-e063-6394a90a1dbb
Version: 8
Effective date: 2025-12-18
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:01:39

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		Aplicare Povidone-Iodine	openfda.brand_name
generic name		POVIDONE-IODINE	openfda.generic_name
manufacturer name		Aplicare Products, LLC	openfda.manufacturer_name
ndc	package	52380-2801-8	openfda.package_ndc
ndc	product	52380-2801	openfda.product_ndc
ndc11	package	52380280108	derived:openfda.package_ndc
rxcui		312564	openfda.rxcui
spl id		4640c80b-048c-1a17-e063-6394a90a1dbb	id
spl set id		1ad9237e-80ee-4769-ba53-9bc1bb667249	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 Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation. Do not use • in the eyes • on individuals allergic or sensitive to iodine 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 Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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