FDA.reportPublic FDA data

GLYTONE Acne Treatment Lotion

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:13:00

Label at a glance#

ProductGlytone Acne Treatment
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Cleanse the skin thoroughly before applying medication. Cover the affected area(s) with a thin layer one to three times daily, or as directed by your physician. 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1 %

Purpose

OTC - PURPOSE SECTION

Acne Treatment

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

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 the eyes. If eye contact occurs, flush thoroughly with water.

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 medication.
  • Cover the affected area(s) with a thin layer one to three times daily, or as directed by your physician.
  • 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.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethoxydiglycol, Propylene Glycol, Glyceryl Laurate, PEG-100 Stearate, Cyclopentasiloxane, Cetearyl Glucoside, Behenyl Alcohol, Bisabolol, Carnosine, Hydrogenated Lecithin, Oryza Sativa (Rice) Bran Extract, Xanthan Gum, Sodium Hydroxide, Polysilicone-11, Disodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Isobutylparaben, Phenoxyethanol

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Treatment LotionAcne Treatment Lotion​​GLYTONE

Acne Treatment Lotion

1.0% Salicylic Acid

NON-IRRITATING FORMULA

NET WT. 56.7 g / 2 OZ.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-709-012023-03-31C16284748780-1ba0f9c33-5de7-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Lotion
64760-709-012023-01-30C16284748780-1ba0f9c33-5de7-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Lotion
64760-709-012021-02-04C16284748780-1ba0f9c33-5de7-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Lotion
64760-709-012021-01-29C16284748780-1ba0f9c33-5de7-a910-e053-dadaa90a0b85GLYTONE Acne Treatment Lotion

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-70964760-709-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIS-ETHOXYDIGLYCOL SUCCINATEYGQ120RH3IIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL LAURATEY98611C087IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CARNOSINE8HO6PVN24WIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
RICE BRANR60QEP13ICIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT
ACRYLIC ACIDJ94PBK7X8SIACT
SALICYLIC ACIDO414PZ4LPZACTIB
ISOBUTYLPARABEN0QQJ25X58GIACT
PEG-100 STEARATEYD01N1999RIACT
DOCOSANOL9G1OE216XYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LEVOMENOL24WE03BX2TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
0f5145a0-005a-e7a5-e063-6294a90a48a957856fe3-4d81-481e-8c4a-bad026ecd40a2024-01-19WarningsExact identifier
spl id: 0f5145a0-005a-e7a5-e063-6294a90a48a9
spl set id: 57856fe3-4d81-481e-8c4a-bad026ecd40a

Reported adverse events (FAERS/openFDA)#

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