GLYTONE DARK SPOT CORRECTOR- hydroquinone liquid

Glytone Dark Spot Corrector by

Drug Labeling and Warnings

Glytone Dark Spot Corrector by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightening

Use

• 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

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

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

When using this product

• 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

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

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

• 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

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

Principal Display Panel

Glytone

Dark Spot Corrector

2% Hydroquinone

30 mL/1 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE DARK SPOT CORRECTOR 
hydroquinone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
KOJIC ACID (UNII: 6K23F1TT52)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM BISULFITE (UNII: TZX5469Z6I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-703-01	1 in 1 CARTON	11/27/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	11/27/2018

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)