FDA.reportPublic FDA data

Glytone Acne Back & Chest Treatment Spray

Manufacturer
GLYTONE LLC
Effective date
2024-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:26

Label at a glance#

ProductAcne Back Chest Treatment
Active ingredientSALICYLIC ACID
Label structure6 sections

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

For external use only.

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 for optimal application.
  • Let dry prior to putting on clothes.
  • Beacuase 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.

Flammable

OTHER SAFETY INFORMATION

Keep away from fire or flame.

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.
  • spray in a well ventilated area. Do not inhale.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SABDARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLA OLEFERA (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.

acneacne

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84262-012-01Acne Back Chest Treatment30 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84262-012ACNE BACK CHEST TREATMENT (SALICYLIC ACID) AEROSOL, SPRAY [GLYTONE LLC]11 package rows20240630_1bf62961-dd95-9c34-e063-6394a90abc5c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84262-01284262-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
SALICYLIC ACIDO414PZ4LPZACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
GLUCONOLACTONEWQ29KQ9POTIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CALCIUM GLUCONATESQE6VB453KIACT
WATER059QF0KO0RIACT
WHITE TEAO0M3396E09IACT
ALCOHOL3K9958V90MIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
SODIUM GLUCONATER6Q3791S76IACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT

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
1bf62961-dd96-9c34-e063-6394a90abc5c1bf62961-dd95-9c34-e063-6394a90abc5c2024-06-28WarningsExact identifier
spl id: 1bf62961-dd96-9c34-e063-6394a90abc5c
spl set id: 1bf62961-dd95-9c34-e063-6394a90abc5c

Reported adverse events (FAERS/openFDA)#

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