Advanced Skin Lightening Cream

Advanced Skin Lightening Cream by

Drug Labeling and Warnings

Advanced Skin Lightening Cream by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ADVANCED SKIN LIGHTENING CREAM- 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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Advanced Skin Lightening Cream

PURPOSE

Skin Bleaching and Correcting

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

Use fingertips to apply a thin layer to the affected areas. Use both morning and night or as directed by a physician.

ACTIVE INGREDIENT

Hydroquinone

DESCRIPTION

Each gram of Advanced Skin Lightening Cream contains 20 mg/g Hydroquinone USP in a nonmedicinal cream base of Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance, 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.

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.

WARNINGS AND 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. 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.

KEEP OUT OF REACH OF CHILDREN

Advanced Skin Lightening Cream should be kept away from Children.

DIRECTIONS

Test for skin sensitivity before using by applying Advanced Skin Lightening 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 cap securely after each use. Store at room temperature (15-30°C / 59-86°F).

HOW SUPPLIED

ADVANCED SKIN LIGHTENING CREAM is available as follows: 60 mL / 2 fl oz.

INACTIVE INGREDIENTS

Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance, 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

Advanced Skin Lightening Cream_Carton Label Advanced Skin Lightening Cream_Carton Label

ADVANCED SKIN LIGHTENING CREAM 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67226-2821
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67226-2821-61 in 1 BOX06/01/201612/02/2016
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A06/01/201612/02/2016
Labeler - Vivier Pharma, Inc. (250996550)

Revised: 2/2020
 

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