GLYTONE Acne BPO Treatment Gel

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:04:09

Label at a glance#

ProductGLYTONE Acne BPO Treatment Gel
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Dosage and administration

Cleanse the skin thoroughly before applying product. Cover the affected area(s) 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 to three times daily or as directed by your physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscre...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Use

INDICATIONS & USAGE SECTION

For the treatment of Acne.

Dries and clears acne blemishes and allows skin to heal.

Penetrates pores to eliminate most acne blemishes, blackheads and whiteheads.

Helps prevent the development of new acne blemishes, blackheads and whiteheads.

Warnings

WARNINGS SECTION

For external use only.

Do not use if you

OTC - DO NOT USE SECTION

have very sensitive skin

are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

avoid unnecessary sun exposure and use a sunscreen.

avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

avoid contact with hair and dyed fabrics, which may be bleached by this product.

skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse the skin thoroughly before applying product.

Cover the affected area(s) 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 to three times daily or as directed by your physician.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature of 68-77 F (22-25 C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 60 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne BPO Treatment Gel

Acne Therapy

5% Micronized Benzoyl Peroxide

Non-Irritating Formula

60 mL/ 2 FL. OZ.

Acne BPO GelAcne BPO Gel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-732-012023-04-04C16284748780-1f386c649-c495-0266-e053-dadaa90a7c1aGLYTONE Acne BPO Treatment Gel
64760-732-012023-01-30C16284748780-1f386c649-c495-0266-e053-dadaa90a7c1aGLYTONE Acne BPO Treatment Gel

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-73264760-732-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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
17401201-75ab-3b80-e063-6394a90a5b75c2d7da18-bad4-8ea8-e053-2a95a90acfcc2024-04-29WarningsExact identifier
spl id: 17401201-75ab-3b80-e063-6394a90a5b75
spl set id: c2d7da18-bad4-8ea8-e053-2a95a90acfcc

Reported adverse events (FAERS/openFDA)#

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