GLYTONE Acne Treatment Lotion

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:13:53

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. 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.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicyclic Acid 1%

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.

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.

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

Cleanse the skin thoroughly before applying medication.

Cover the affected area(s) 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 or as directed by your physician.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature of 68-77 F (22-25 C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), C12-15 ALKYL BENZOATE, PROPANEDIOL, BUTYLENE GLYCOL, C13-15 ALKANE, DIMETHYL ISOSORBIDE, CETEARYL ALCOHOL, BEHENYL ALCOHOL, POLYACRYLATE-13, GLYCERYL STEARATE, ARACHIDYL ALCOHOL, BAKUCHIOL, BISABOLOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, POLYISOBUTENE, XANTHAN GUM, AMINOMETHYL PROPANOL, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, DISODIUM EDTA, ARACHIDYL GLUCOSIDE, CARNOSINE, POLYSORBATE 20, SORBITAN ISOSTEARATE, GLUCOSE, ARCTIUM LAPPA ROOT EXTRACT

Principal Display Panel - 60 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GLYTONE

Acne Treatment Lotion

Acne Therapy

1% Salicylic Acid Bakuchiol

Non-Irritating Formula

60 mL / 2 FL. OZ.

Acne Treatment LotionAcne Treatment Lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-731-012023-04-04C16284748780-1f386c649-c918-0266-e053-dadaa90a7c1aGLYTONE Acne Treatment Lotion
64760-731-012023-01-30C16284748780-1f386c649-c918-0266-e053-dadaa90a7c1aGLYTONE Acne Treatment Lotion

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-73164760-731-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
0f5112f9-2fd3-626e-e063-6394a90a98f9c972b44c-d932-8428-e053-2995a90a026a2024-01-19WarningsExact identifier
spl id: 0f5112f9-2fd3-626e-e063-6394a90a98f9
spl set id: c972b44c-d932-8428-e053-2995a90a026a

Reported adverse events (FAERS/openFDA)#

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