FDA.reportPublic FDA data

GLYTONE Acne BPO Clearing Cleanser

Manufacturer
Pierre Fabre USA Inc.
Effective date
2023-03-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:32:58

Label at a glance#

ProductGLYTONE Acne BPO Clearing Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Dosage and administration

Dispense a small amount into hand and mix with a little water. Apply a thin layer over entire affected area in a circular motion, rinse thoroughly with warm water two times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other d...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 4.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.


Do not use if you

OTC - DO NOT USE SECTION

  • have a 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 the eyes, lips, and mouth
  • 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense a small amount into hand and mix with a little water.
  • Apply a thin layer over entire affected area in a circular motion, rinse thoroughly with warm water two times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times or as directed by a doctor.
  • 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 68-77 o F (25-25 o C). Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, COCAMIDOPROPYL BETAINE, SODIUM C14-16 OLEFIN SULFONATE, HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE, DIPROPYLENE GLYCOL, 1,3-BUTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, XANTHAN GUM, EUPHORBIA CERIFERA (CANDELILLA) WAX, HYDROXYPROPYL METHYLCELLULOSE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, PEG-11 AVOCADO GLYCERIDES


Principal Display Panel - 200 ml Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BPO Clearing CleanserBPO Clearing Cleanser

GLYTONE

Acne BPO Clearing

Cleanser

4.5

Encapsulated Benzoyl Peroxide

200 mL / 6.7 FL. OZ.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-712-012023-04-14C16284748780-1ba0f9c33-20d8-a910-e053-dadaa90a0b85GLYTONE Acne BPO Clearing Cleanser
64760-712-012023-01-30C16284748780-1ba0f9c33-20d8-a910-e053-dadaa90a0b85GLYTONE Acne BPO Clearing Cleanser
64760-712-012021-02-10C16284748780-1ba0f9c33-20d8-a910-e053-dadaa90a0b85GLYTONE Acne BPO Clearing Cleanser
64760-712-012021-01-29C16284748780-1ba0f9c33-20d8-a910-e053-dadaa90a0b85GLYTONE Acne BPO Clearing Cleanser

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-71264760-712-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
DIPROPYLENE GLYCOLE107L85C40IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SHEA BUTTERK49155WL9YIACT
XANTHAN GUMTTV12P4NEEIACT
CANDELILLA WAXWL0328HX19IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-11 AVOCADO GLYCERIDESYLY4A64409IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
f80d325d-d00c-bd3a-e053-6294a90a690df49659d5-fec4-43b4-9dca-9d4c365ec0692023-03-29WarningsExact identifier
spl id: f80d325d-d00c-bd3a-e053-6294a90a690d
spl set id: f49659d5-fec4-43b4-9dca-9d4c365ec069

Reported adverse events (FAERS/openFDA)#

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