FDA.reportPublic FDA data

Glytone Acne Clearing Cleanser

Manufacturer
Pierre Fabre USA | ACCU BIO-CHEM LABS
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:37

Label at a glance#

ProductGlytone Acne Clearing Cleanser
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Dispense a small amount into hand and mix with a little water. Apply a thin layer over the entire affected area in a circular motion and 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 daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treament

Use

INDICATIONS & USAGE SECTION

  • 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.

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

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

  • Dispense a small amount into hand and mix with a little water.
  • Apply a thin layer over the entire affected area in a circular motion and 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 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.

Other information

OTHER SAFETY INFORMATION

Store at room temperature of 68-77° F (20-25° C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, METHYLPROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, SODIUM LAUROYL SARCOSINATE, HEXYLENE GLYCOL, CAPRYLOYL GLYCINE, CLEOME GYNANDRA LEAF EXTRACT, POTASSIUM SORBATE, PROPANEDIOL, SODIUM BENZOATE, SODIUM HYDROXIDE, XYLITYLGLUCOSIDE.

Principal Display Panel 200mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne Clearing Cleanser

2% Salicylic Acid

200 mL/6.7 Fl. Oz.

Acne Clearing CleanserAcne Clearing Cleanser

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-705-012023-04-04C16284748780-1f386c649-cbd2-0266-e053-dadaa90a7c1aGlytone Acne Clearing Cleanser
64760-705-012023-01-30C16284748780-1f386c649-cbd2-0266-e053-dadaa90a7c1aGlytone Acne Clearing Cleanser

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-705GLYTONE ACNE CLEARING CLEANSER (SALICYLIC ACID) LIQUID [PIERRE FABRE USA]4Legacy NDC20240430_91474300-cebe-30a4-e053-2a95a90aae7f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-70564760-705-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITYLGLUCOSIDEO0IEZ166FBIACT
SODIUM BENZOATEOJ245FE5EUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
WATER059QF0KO0RIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CLEOME GYNANDRA LEAF505381240SIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM LAURYL SARCOSINATE5PGH842FAUIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
173fdc3e-ab2c-2f50-e063-6394a90af02a91474300-cebe-30a4-e053-2a95a90aae7f2024-04-29WarningsExact identifier
spl id: 173fdc3e-ab2c-2f50-e063-6394a90af02a
spl set id: 91474300-cebe-30a4-e053-2a95a90aae7f

Reported adverse events (FAERS/openFDA)#

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