Glytone Acne BPO Treatment Gel

Manufacturer
Glytone, LLC | Covalence Laboratories, Inc
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:17

Label at a glance#

ProductGlytone Acne BPO Treatment Gel
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Medicated, non-whitening lotion helps fight existing acne and prevent future breakouts from forming while calming visible redness.

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 5%

OTC - PURPOSE SECTION

BENZOYL PEROXIDE 5% - prevent future breakouts from forming while calming visible redness.

WARNINGS SECTION

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.

INACTIVE INGREDIENT SECTION

WATER (AQUA), PROPANEDIOL, DIMETHYL ISOSORBIDE, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOHEXADECANE, HYDROXYACETOPHENONE, POLYSORBATE 80, POLYGLYCERYL-2 ISOSTEARATE, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, SODIUM CITRATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CITRIC ACID, DIETHYLHEXYL SODIUM SULFOSUCCINATE, CARBOMER, SODIUM HYDROXIDE, ETHYLHEXYLGLYCERIN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, DIMETHICONE, ARCTIUM LAPPA ROOT EXTRACT, PHENOXYETHANOL, OLEANOLIC ACID, PEG-40 STEARATE, SILICA, SORBITAN STEARATE, TOCOPHEROL

DOSAGE & ADMINISTRATION SECTION

Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer one to three times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN1
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD1
308694benzoyl peroxide 5 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84262-030-01Glytone Acne BPO Treatment Gel60 g in 1 TUBEGEL601

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84262-03084262-030-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glytone Acne BPO Treatment GelBENZOYL PEROXIDE GELGlytone, LLC4e68cba9-8358-1ee8-e063-6294a90ae4be2026-04-02WarningsExact identifier
ndc (package): 84262-030-01
ndc (product): 84262-030
ndc11 (package): 84262003001
spl id: 4e68cba9-8359-1ee8-e063-6294a90ae4be
spl set id: 4e68cba9-8358-1ee8-e063-6294a90ae4be

Reported adverse events (FAERS/openFDA)#

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