FDA.reportPublic FDA data

Glytone Acne Clarifying Treatment Mask

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:03:53

Label at a glance#

ProductGlytone Acne Treatment Mask
Active ingredientSULFUR
Label structure9 sections

Dosage and administration

Before first use, break the safety seal by twisting the inverted cap over the star-shaped seal. Cleanse the skin thoroughly before applying this mask. Apply a generous amount to the entire face and neck, or as directed by your physician. Avoid eyes, nostrils, and lips. Leave on skin for 20-25 minutes. Remove with lukewarm water in a gentle circular motion. Pat dry. Use one to three times a week, or as directed by ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 6.4%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use  For the treatment of acne.

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

SPL UNCLASSIFIED SECTION

For external use only

Flammable: Keep away from fire or flame

Flammable: Keep away from fire or flame.

SPL UNCLASSIFIED SECTION

Do not use on

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

  • apply only to areas with acne
  • 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, flush thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if excessive skin irritation develops or increases.

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

  • Before first use, break the safety seal by twisting the inverted cap over the star-shaped seal.

  • Cleanse the skin thoroughly before applying this mask.

  • Apply a generous amount to the entire face and neck, or as directed by your physician.

  • Avoid eyes, nostrils, and lips.

  • Leave on skin for 20-25 minutes.

  • Remove with lukewarm water in a gentle circular motion. Pat dry.

  • Use one to three times a week, or as directed by your physician.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, BENTONITE, ISOPROPYL ALCOHOL, KAOLIN, ZINC OXIDE, GLYCERIN, CALCIUM OXIDE, COCAMIDE MIPA, FRAGRANCE, METHYLPARABEN, SODIUM LAURYL SULFATE.

Principal Display Panel - 85 g - Glytone Acne Treatment Mask Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne

Treatment

Mask

ACNE THERAPY

6.4% SULFUR

NET WT. 85 g / 3 OZ.

AcneTreatmentMaskAcneTreatmentMask

Principal Display Panel - 85 g - Glytone Acne Clarifying Treatment Mask Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

ACNE CLARIFYING TREATMENT MASK

ACNE THERAPY

6.4% SULFUR

1% GLYCOLIC ACID

1% LACTIC ACID

NET WT. 85 G / 3 OZ.

Acne Clarifying Treatment MaskAcne Clarifying Treatment Mask

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-710-012023-04-04C16284748780-1ba0f9c33-2b75-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Mask
64760-710-012023-01-30C16284748780-1ba0f9c33-2b75-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Mask
64760-710-012021-02-03C16284748780-1ba0f9c33-2b75-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Mask
64760-710-012021-01-29C16284748780-1ba0f9c33-2b75-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Mask

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-71064760-710-01
64760-71464760-714-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
ISOPROPYL ALCOHOLND2M416302IACT
KAOLIN24H4NWX5COIACT
ZINC OXIDESOI2LOH54ZIACT
GLYCERINPDC6A3C0OXIACT
LIME (CALCIUM OXIDE)C7X2M0VVNHIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
SULFUR70FD1KFU70ACTIB
KAOLIN24H4NWX5COIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCOLIC ACID0WT12SX38SIACT
POLYSORBATE 207T1F30V5YHIACT
LACTIC ACID LACTATE, L-26T86KT372IACT
CAPRYLYL GLYCOL00YIU5438UIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
GLYCERINPDC6A3C0OXIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
PENTYLENE GLYCOL50C1307PZGIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALOE VERA LEAFZY81Z83H0XIACT
BISABOLOL OXIDE A16AE65F94YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM GLUCONATER6Q3791S76IACT
TROPOLONE7L6DL16P1TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL RICINOLEATEZUE0CEL42OIACT

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
178e03a2-1f79-d16b-e063-6394a90a2aa1af005abb-c516-4e81-bf46-2792723835cc2024-05-03WarningsExact identifier
spl id: 178e03a2-1f79-d16b-e063-6394a90a2aa1
spl set id: af005abb-c516-4e81-bf46-2792723835cc

Reported adverse events (FAERS/openFDA)#

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