GLYTONE DARK SPOT CORRECTOR- hydroquinone liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
Available from:
Pierre Fabre USA Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Lightening - 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.
Authorization status:
OTC monograph not final
Authorization number:
64760-703-01

GLYTONE DARK SPOT CORRECTOR- hydroquinone liquid

Pierre Fabre USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Glytone Dark Spot Corrector

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.

GLYTONE DARK SPOT CORRECTOR

hydroquinone liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 476 0 -70 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO Q UINO NE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

HYDROQUINONE

2 g in 10 0 mL

Pierre Fabre USA Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

KO JIC ACID (UNII: 6 K23F1TT52)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

NO RDIHYDRO GUAIARETIC ACID, ( +/-) - (UNII: 7PZ73W4ZNR)

WATER (UNII: 0 59 QF0 KO0 R)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

GLYCO LIC ACID (UNII: 0 WT12SX38 S)

SO DIUM BISULFITE (UNII: TZX546 9 Z6 I)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 476 0 -70 3-0 1

1 in 1 CARTON

11/27/20 18

12/31/20 21

1

30 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt358 A

11/27/20 18

12/31/20 21

Labeler -

Pierre Fabre USA Inc. (117196928)

Registrant -

Pierre Fabre USA Inc. (117196928)

Revised: 6/2020

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