Peviderm Pramoxine Hydrocholride 1%

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: Peviderm Pramoxine Hydrocholride 1%
Generic name: PRAMOXINE HYDROCHLORIDE
Manufacturer: Stratus Pharmaceuticals Inc
Product type: HUMAN OTC DRUG
SPL set ID: 680b40fa-1922-443a-a4b0-7c3f6a2b847d
SPL ID: 119ef16e-c873-41df-9e98-4ccade286a85
Version: 2
Effective date: 2024-11-07
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 05:53:35

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		M017	openfda.application_number
brand name		Peviderm Pramoxine Hydrocholride 1%	openfda.brand_name
generic name		PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Stratus Pharmaceuticals Inc	openfda.manufacturer_name
ndc	package	58980-913-80	openfda.package_ndc
ndc	product	58980-913	openfda.product_ndc
ndc11	package	58980091380	derived:openfda.package_ndc
spl id		119ef16e-c873-41df-9e98-4ccade286a85	id
spl set id		680b40fa-1922-443a-a4b0-7c3f6a2b847d	set_id
unii		88AYB867L5	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 When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Reported adverse events (FAERS/openFDA)#

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