Aplicare

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
Generic name: POVIDONE IODINE
Manufacturer: Aplicare Products LLC
Product type: HUMAN OTC DRUG
SPL set ID: 0b3e4f14-e9e6-2f2e-e063-6394a90ab2e1
SPL ID: 4640ba32-cf35-18ad-e063-6394a90a4592
Version: 3
Effective date: 2025-12-18
Source export date: 2026-10-30
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:58:50

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	openfda.brand_name
generic name		POVIDONE IODINE	openfda.generic_name
manufacturer name		Aplicare Products LLC	openfda.manufacturer_name
ndc	package	52380-0946-3	openfda.package_ndc
ndc	product	52380-0946	openfda.product_ndc
ndc11	package	52380094603	derived:openfda.package_ndc
rxcui		797730	openfda.rxcui
spl id		4640ba32-cf35-18ad-e063-6394a90a4592	id
spl set id		0b3e4f14-e9e6-2f2e-e063-6394a90ab2e1	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 Do not use if allergic to iodine in the eyes or apply over large areas of the body longer than 1 week unless directed by a doctor For external use only Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours or gets worse in case of deep or puncture wounds, animal bites, or serious burns Avoid pooling beneath patient 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.