Hermon Balanitis Cream

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: Hermon Balanitis Cream
Generic name: SULFUR 1X HPUS
Manufacturer: Beautivity LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3dba4e4b-8224-6a96-e063-6394a90a9129
SPL ID: 3dba4e4b-8225-6a96-e063-6394a90a9129
Version: 1
Effective date: 2025-09-01
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		M005	openfda.application_number
brand name		Hermon Balanitis Cream	openfda.brand_name
generic name		SULFUR 1X HPUS	openfda.generic_name
manufacturer name		Beautivity LLC	openfda.manufacturer_name
ndc	package	85398-013-01	openfda.package_ndc
ndc	product	85398-013	openfda.product_ndc
ndc11	package	85398001301	derived:openfda.package_ndc
spl id		3dba4e4b-8225-6a96-e063-6394a90a9129	id
spl set id		3dba4e4b-8224-6a96-e063-6394a90a9129	set_id
unii		70FD1KFU70	openfda.unii
unii		H8FJJ6KX5Y	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

For external use only children under 2 years of age unless directed by a doctor avoid contact with the eves. lf contact occurs, rinse the eyes very thoroughly with water if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement. lf 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.