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Clarite 4

Medically reviewed by Drugs.com. Last updated on Oct 28, 2021.

Dosage form: cream
Ingredients: HYDROQUINONE 4g in 100mL
Labeler: Vivier Pharma, Inc.
NDC Code: 67226-2040

Clarite 4

Active Ingredient

Hydroquinone USP (4%)

Indication

Skin Bleaching and Correcting

Indication

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

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

Keep out of reach of children.

Directions

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).

Non-Medicinal Ingredients

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

CLARITE 4 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:67226-2040-61 TUBE in 1 BOX
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A05/30/2014
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
NameAddressID/FEIOperations
Vivier Pharma, Inc.250996550manufacture(67226-2040)

 
Vivier Pharma, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.