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Advanced Skin Lightening Serum

Medically reviewed on August 15, 2017

Dosage form: liquid
Ingredients: HYDROQUINONE 2g in 100mL
Labeler: Vivier Pharma, Inc.
NDC Code: 67226-2621

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.

Advanced Skin Lightening Serum

Active Ingredient

Hydroquinone 2% USP in a nonmedicinal liquid gel base containing Vitamin C IDS™ (L-Ascorbic Acid USP).

Indication

Skin Lightening

Indication

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or other areas of unwanted melanin hyperpigmentation that may occur as a result of pregnancy or from the use of oral contraceptives.

Precautions

For external use only. Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water. Keep out of
reach of children. Vitamin C (L-Ascorbic Acid USP) may cause a slight tingling sensation in some people. This is normal and will usually diminish with time. See package insert for more details.

Precautions

Keep out of reach of children.

Directions

Remove and discard white cap and replace with dropper. Place two to three drops in palm of hand and use fingertips to apply a thin layer
to face, neck, chest and back of hands as desired. Use both morning and night or as directed by a physician. Close dropper cap securely after each use. Gradual lightening of the discoloration can be expected in most cases. L-Ascorbic Acid USP will tend to oxidize and change to a light yellow color with time. This change in color is natural and will not significantly alter the product’s effectiveness. Store at room temperature (15-25ºC / 59-77ºF).

Non-Medicinal Ingredients

CITRUS GRANDIS (GRAPEFRUIT) EXTRACT, ETHOXYDIGLYCOL, FRAGRANCE, L-ASCORBIC ACID USP, PROPYLENE GLYCOL, WATER/EAU.

Principal Display Panel

ADVANCED SKIN LIGHTENING SERUM 
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2621
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ASCORBIC ACID 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:67226-2621-31 BOTTLE, DROPPER in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A09/30/2016
Labeler - Vivier Pharma, Inc. (250996550)
Establishment
NameAddressID/FEIOperations
Entreprises ImportFAB Inc.248586117manufacture(67226-2621)

 
Vivier Pharma, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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