Clarite 4

Manufacturer: Vivier Pharma, Inc.
Effective date: 2013-11-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:07

Label at a glance#

ProductClarite 4

Active ingredientHYDROQUINONE

Label structure8 sections

Dosage and administration

Use fingertips to apply a thin layer to affected areas. Use both morning and night or as directed by a physician. Gradual lightening of the discolored area can be expected in most cases. Close cap securely after each use. Store at room temperature (15-30°C / 59-86°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone USP (4%)

Indication

OTC - PURPOSE SECTION

Skin Bleaching and Correcting

Indication

INDICATIONS & USAGE SECTION

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation that can occur as a result of pregnancy or the use of oral contraceptives.

Precautions

WARNINGS SECTION

For external use only. Use only on the advice of a physician. A mild transient stinging may occur for people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid usage around the eyes and lips.

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance/Parfum (Carubba C6929), Glycerin, Lactic Acid, L-Ascorbic Acid USP, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Water/Eau.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARITE 4_PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67226-2040-6	2025-01-20	C162847	48780-1	9855e2a2-34cb-60a7-e053-dbdaa90a05bd	Clarite 4
67226-2040-6	2019-11-27	C162847	48780-1	9855e2a2-34cb-60a7-e053-dbdaa90a05bd	Clarite 4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	2
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	2
PPG-2 MYRISTYL ETHER PROPIONATE	INACTIVE INGREDIENT	88R97D8U8A	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Clarite 4
Hydroquinone
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
EDETATE DISODIUM
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
LACTIC ACID
ASCORBIC ACID
METHYLPARABEN
PHENYL TRIMETHICONE
PPG-2 MYRISTYL ETHER PROPIONATE
PROPYLPARABEN
SODIUM CETOSTEARYL SULFATE
SODIUM LAURYL SULFATE
SODIUM METABISULFITE
.ALPHA.-TOCOPHEROL ACETATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67226-2040	67226-2040-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
GLYCERIN	PDC6A3C0OX	IACT
LACTIC ACID	33X04XA5AT	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
PPG-2 MYRISTYL ETHER PROPIONATE	88R97D8U8A	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 513 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 43 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBCUTANEOUS		43 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRACARDIAC	0.01 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / IONTOPHORESIS	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	DROPS / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2c2423f6-c21f-1dfb-e063-6394a90a392f			4fdafa5b-0738-493e-9bd5-cd1edaa14be0	2025-01-20	Warnings	Exact identifier spl set id: 4fdafa5b-0738-493e-9bd5-cd1edaa14be0

Reported adverse events (FAERS/openFDA)#

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