Prep Solution Topical Antiseptic Microbicide

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: Prep Solution Topical Antiseptic Microbicide
Generic name: POVIDONE-IODINE
Manufacturer: Degasa SA De CV
Product type: HUMAN OTC DRUG
SPL set ID: dd34cc57-8a8c-4189-b517-61448f961c9e
SPL ID: 097358e0-eaba-c991-e063-6294a90acb81
Version: 6
Effective date: 2023-11-05
Source export date: 2026-10-27
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:46:59

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 · 23 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		Prep Solution Topical Antiseptic Microbicide	openfda.brand_name
generic name		POVIDONE-IODINE	openfda.generic_name
manufacturer name		Degasa SA De CV	openfda.manufacturer_name
ndc	package	67326-350-04	openfda.package_ndc
ndc	package	67326-350-10	openfda.package_ndc
ndc	package	67326-350-07	openfda.package_ndc
ndc	package	67326-350-06	openfda.package_ndc
ndc	package	67326-350-09	openfda.package_ndc
ndc	package	67326-350-08	openfda.package_ndc
ndc	package	67326-350-05	openfda.package_ndc
ndc	product	67326-350	openfda.product_ndc
ndc11	package	67326035004	derived:openfda.package_ndc
ndc11	package	67326035008	derived:openfda.package_ndc
ndc11	package	67326035006	derived:openfda.package_ndc
ndc11	package	67326035007	derived:openfda.package_ndc
ndc11	package	67326035009	derived:openfda.package_ndc
ndc11	package	67326035005	derived:openfda.package_ndc
ndc11	package	67326035010	derived:openfda.package_ndc
rxcui		312564	openfda.rxcui
spl id		097358e0-eaba-c991-e063-6294a90acb81	id
spl set id		dd34cc57-8a8c-4189-b517-61448f961c9e	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: In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns. Stop use and ask a doctor if Irritation and redness develop and if conditions persist for more than 72 hours. Keep out of reach of children If swallowed, 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.