Label: ADVANCED SKIN LIGHTENING SERUM- hydroquinone liquid
- NDC Code(s): 67226-2621-3
- Packager: Vivier Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 19, 2018
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- Active Ingredient
Hydroquinone 2% USP in a nonmedicinal liquid gel base containing Vitamin C IDS™ (L-Ascorbic Acid USP).Close
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.Close
For external use only. Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water. Keep out ofClose
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.
Keep out of reach of children.Close
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 layerClose
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.Close
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
ADVANCED SKIN LIGHTENING SERUM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength GRAPEFRUIT (UNII: O82C39RR8C) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ASCORBIC ACID (UNII: PQ6CK8PD0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2621-3 1 in 1 BOX 09/30/2016 12/01/2018 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 09/30/2016 12/01/2018 Labeler - Vivier Pharma, Inc. (250996550) Establishment Name Address ID/FEI Business Operations Entreprises ImportFAB Inc. 248586117 manufacture(67226-2621)