FDA.reportPublic FDA data

Glytone Dark Spot Corrector

Manufacturer
Pierre Fabre USA Inc.
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:24:36

Label at a glance#

ProductGlytone Dark Spot Corrector
Active ingredientHYDROQUINONE
Label structure8 sections

Dosage and administration

Apply a small amount as a thin layer on the affected area twice daily, or as directed by a doctor. If no improvement is seen after 3 months of treatment, discontinue use. Lightening effect of this product might not be noticeable when used on very dark skin. To prevent darkening from reoccurring, avoid sun exposure to treated areas by using a sunscreen with broad spectrum SPF 15 or higher and wearing protective clo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightening

Use

INDICATIONS & USAGE SECTION

  • Lightens dark (brownish) discolorations in the skin such as: freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

WARNINGS SECTION

For externaly use only

Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing, and severe asthma attack in certain susceptible persons.

Do not use

OTC - DO NOT USE SECTION

  • on children under 12 years of age unles directed by a doctor.
  • on broken or severely irritated skin

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • some users may experience a mild skin irritation.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation becomes severe or allergic reactions occur such as hives, itching or wheezing.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

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

  • Apply a small amount as a thin layer on the affected area twice daily, or as directed by a doctor. If no improvement is seen after 3 months of treatment, discontinue use. Lightening effect of this product might not be noticeable when used on very dark skin.
  • To prevent darkening from reoccurring, avoid sun exposure to treated areas by using a sunscreen with broad spectrum SPF 15 or higher and wearing protective clothing.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 68-77° F (20-25° C). Do not expose to heat above 86° F (30° C) or direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, GLYCOLIC ACID, AMINOMETHYL PROPANOL, SODIUM METABISULFITE, KOJIC ACID, DISODIUM EDTA, HYDROXYETHYLCELLULOSE, NORDIHYDROGUAIARETIC ACID, SODIUM BISULFITE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glytone

Dark Spot Corrector

2% Hydroquinone

30 mL/1 FL. OZ.

DarkSpotCorrectorDarkSpotCorrector

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-70364760-703-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
KOJIC ACID6K23F1TT52IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM METABISULFITE4VON5FNS3CIACT
NORDIHYDROGUAIARETIC ACID, (+/-)-7PZ73W4ZNRIACT
HYDROQUINONEXV74C1N1AEACTIB
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCOLIC ACID0WT12SX38SIACT
SODIUM BISULFITETZX5469Z6IIACT

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
a8c5b1ed-e6e1-29dd-e053-2a95a90a01a791490ac8-f7e1-555a-e053-2995a90a5e312020-06-23WarningsExact identifier
spl id: a8c5b1ed-e6e1-29dd-e053-2a95a90a01a7
spl set id: 91490ac8-f7e1-555a-e053-2995a90a5e31

Reported adverse events (FAERS/openFDA)#

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