FDA.reportPublic FDA data

GLYTONE Acne Back and Chest Treatment Spray

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:04:08

Label at a glance#

ProductGlytone Acne Back and Chest Treatment
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily. Pump works upside down and for optimal application. Let dry prior to putting on clothes. 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

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

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 use only one topical acne medication at a time.
  • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • Spray in a well ventilated area. Do not inhale.

Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

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

Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily.

Pump works upside down and for optimal application.

Let dry prior to putting on clothes.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SARBARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLIA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLIA OLEIFERA (GREEN TEA) LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SODIUM HYDROXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne Back & Chest Treatment Spray

ACNE THERAPY

2% Salicylic Acid Acne Medication Gluconolactone (PHA) Aloe

240 mL / 8.0 FL. OZ.

labellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-711-012023-04-21C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-022023-04-21C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-735-012023-04-21C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-012023-01-30C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-022023-01-30C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-735-012023-01-30C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-012021-02-03C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-022021-02-03C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-012021-01-29C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray
64760-711-022021-01-29C16284748780-1ba0f9c33-3fc9-a910-e053-dadaa90a0b85GLYTONE Acne Back and Chest Treatment Spray

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-73564760-735-01
64760-71164760-711-01, 64760-711-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CENTELLA ASIATICA7M867G6T1UIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM HYDROXIDE55X04QC32IIACT
CALCIUM GLUCONATESQE6VB453KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM GLUCONATER6Q3791S76IACT
GLUCONOLACTONEWQ29KQ9POTIACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYSORBATE 207T1F30V5YHIACT
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
17406627-523d-4f4d-e063-6394a90a306c72317d9f-7036-422c-90fc-8b6c129328252024-04-29WarningsExact identifier
spl id: 17406627-523d-4f4d-e063-6394a90a306c
spl set id: 72317d9f-7036-422c-90fc-8b6c12932825

Reported adverse events (FAERS/openFDA)#

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