Glytone Acne BPO Treatment Gel

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: Glytone Acne BPO Treatment Gel
Generic name: BENZOYL PEROXIDE GEL
Manufacturer: Glytone, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4e68cba9-8358-1ee8-e063-6294a90ae4be
SPL ID: 4e68cba9-8359-1ee8-e063-6294a90ae4be
Version: 1
Effective date: 2026-04-02
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:07

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		Glytone Acne BPO Treatment Gel	openfda.brand_name
generic name		BENZOYL PEROXIDE GEL	openfda.generic_name
manufacturer name		Glytone, LLC	openfda.manufacturer_name
ndc	package	84262-030-01	openfda.package_ndc
ndc	product	84262-030	openfda.product_ndc
ndc11	package	84262003001	derived:openfda.package_ndc
rxcui		308694	openfda.rxcui
spl id		4e68cba9-8359-1ee8-e063-6294a90ae4be	id
spl set id		4e68cba9-8358-1ee8-e063-6294a90ae4be	set_id
unii		W9WZN9A0GM	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. Do not use: - on damaged or broken skin. - as a sunscreen for sunbathing. When using this product: - keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if: - rash occurs. Keep out of reach of children. Do not swallow. 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.