FDA.reportPublic FDA data

Glytone Acne Spot Treatment

Manufacturer
Pierre Fabre USA
Effective date
2023-01-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:33:31

Label at a glance#

ProductGlytone Acne Spot Treatment
Active ingredientRESORCINOL, SULFUR
Label structure7 sections

Indications and uses

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.

Dosage and administration

Cleanse the skin thoroughly before applying this product. Cover the 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 to 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Resorcinol 2 %

Sulfur 8 %

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

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 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
  • rinse right away with water if it gets in eyes
  • 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if skin irritation occurs or gets worse

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 this product.
  • Cover the 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 to 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, PROPYLENE GLYCOL,ALCOHOL DENAT., POLYSORBATE 20,CAPRYLIC/CAPRIC TRIGLYCERIDE,MAGNESIUM ALUMINUM SILICATE,SODIUM STEAROYL GLUTAMATE,CETEARYL ALCOHOL, GLYCERYLSTEARATE, POLYSORBATE 60, CHLOROXYLENOL, ETHYLHEXYLGLYCERIN,FRAGRANCE, PHENOXYETHANOL,POLYGLYCERYL-6 PALMITATE/SUCCINATE,
XANTHAN GUM, IRON OXIDES,TITANIUM DIOXIDE.

Principal Display Panel 30 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne Tinted Spot Treatment

2.0 Resorcinol

8.0 Sulfur

30 mL / 1 FL. OZ AcneTintedAcneTinted

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-708-022023-04-04C16284748780-1ba0f9c33-1689-a910-e053-dadaa90a0b85GLYTONE Acne Tinted Spot Treatment
64760-708-022023-01-30C16284748780-1ba0f9c33-1689-a910-e053-dadaa90a0b85GLYTONE Acne Tinted Spot Treatment
64760-708-022021-02-03C16284748780-1ba0f9c33-1689-a910-e053-dadaa90a0b85GLYTONE Acne Tinted Spot Treatment
64760-708-022021-01-29C16284748780-1ba0f9c33-1689-a910-e053-dadaa90a0b85GLYTONE Acne Tinted Spot Treatment

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-70864760-708-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
POLYSORBATE 60CAL22UVI4MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
BROWN IRON OXIDE1N032N7MFOIACT
XANTHAN GUMTTV12P4NEEIACT
CHLOROXYLENOL0F32U78V2QIACT
RESORCINOLYUL4LO94HKACTIB
SULFUR70FD1KFU70ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
FARNESOLEB41QIU6JLIACT
ALCOHOL3K9958V90MIACT
POLYGLYCERIN-6M51422LRAMIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LINALOOL, (+/-)-D81QY6I88EIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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
0f3b2665-0860-6c64-e063-6394a90ad31199b23ef3-5b16-4364-9ff7-4b236978e0482024-01-18WarningsExact identifier
spl set id: 99b23ef3-5b16-4364-9ff7-4b236978e048

Reported adverse events (FAERS/openFDA)#

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