CORRECTOR LIGHT- hydroquinone lotion 
Vivier Pharma, 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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Corrector Light - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CorrectorLight_PackageLabel_PrincipalDisplayPanel

Corrector Light - OTC - ACTIVE INGREDIENT SECTION

Hydroquinone USP 2%

Corrector Light - OTC - PURPOSE SECTION

The purpose of Corrector Light is 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 from the use of oral contraceptives.

Corrector Light - OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Corrector Light should be kept out of reach of children

Corrector Light - INDICATIONS & USAGE SECTION

Corrector Light is used 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 from the use of oral contraceptives.

Corrector Light - WARNINGS SECTION

Corrector Light - WARNINGS - 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. Contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions (hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons. Do not use this product if you are pregnant or nursing unless instructed by a physician.

CONTRAINDICATIONS -

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Corrector Light - DOSAGE & ADMINISTRATION SECTION

Test for skin sensitivity before using by applying Corrector Light Hydroquinone Cream to an area of unbroken skin about 25 mm in diameter. If excessive irritation, rash or other reaction develops within 24 hours, discontinue use. Use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician. Depigmentation is a gradual process and results should be expected within 12 weeks of daily use. To maintain results, use several times a week. If no improvement is seen within 8 weeks of regular use, discontinue use. Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin. Close dropper cap securely after each use. Store at room temperature (15-30°C / 59-86°F).

Corrector Light - INACTIVE INGREDIENT SECTION

Inactive ingredients in Corrector Light include Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance/Parfum, 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

CORRECTOR LIGHT 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2820
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2   in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:67226-2820-61 in 1 BOX
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A09/01/2013
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
NameAddressID/FEIBusiness Operations
Vivier Pharma, Inc.250996550manufacture(67226-2820)

Revised: 08/2013
 
Vivier Pharma, Inc.