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: 91aef86d-ce8b-45be-bce9-74450292e0cd
SPL ID: 3dd65ceb-91c2-da2e-e063-6394a90a62cc
Version: 8
Effective date: 2025-09-02
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 05:57:22

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	52380-4801-8	openfda.package_ndc
ndc	product	52380-4801	openfda.product_ndc
ndc11	package	52380480108	derived:openfda.package_ndc
rxcui		312564	openfda.rxcui
spl id		3dd65ceb-91c2-da2e-e063-6394a90a62cc	id
spl set id		91aef86d-ce8b-45be-bce9-74450292e0cd	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 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.