PRAX

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: PRAX
Generic name: PRAMOXINE HYDROCHLORIDE
Manufacturer: AvPAK
Product type: HUMAN OTC DRUG
SPL set ID: dc646399-91ba-5cc1-e053-2a95a90a4f9c
SPL ID: 47fbf804-a248-931b-e063-6294a90abc2b
Version: 4
Effective date: 2026-01-09
Source export date: 2026-10-27
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/eeb012fd0992efa4f76b2aef09dd5f84150b96392c46717c44deabcc4e3581c1/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:37:40

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		M017	openfda.application_number
brand name		PRAX	openfda.brand_name
generic name		PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		AvPAK	openfda.manufacturer_name
ndc	package	50268-682-15	openfda.package_ndc
ndc	product	50268-682	openfda.product_ndc
ndc11	package	50268068215	derived:openfda.package_ndc
rxcui		1246075	openfda.rxcui
spl id		47fbf804-a248-931b-e063-6294a90abc2b	id
spl set id		dc646399-91ba-5cc1-e053-2a95a90a4f9c	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. Do not exceed the recommended daily dosage unless directed by a doctor put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens symptoms do not improve within 7 days allergic reactions develop to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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