Label: ACTIVATOR LIGHT- hydroquinone lotion
- NDC Code(s): 67226-2720-6
- Packager: Vivier Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient
Hydroquinone USP (2%)
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.Close
For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Use only on the advice of a physician. Contains Sodium Metabisulfite. See package insert for complete details.Close
keep out of reach of childrenClose
Use fingertips to apply a thin layer to affected areas. Use at 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).Close
- Non-Medicinal Ingredients
Butylated Hydroxy Toluene, 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, Triethanolamine Salicylate, Water/Eau.Close
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67226-2720 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE 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 TROLAMINE SALICYLATE WATER Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2720-6 1 in 1 BOX 1 60 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 09/01/2013 Labeler - Vivier Pharma, Inc. (250996550) Establishment Name Address ID/FEI Business Operations Vivier Pharma, Inc. 250996550 manufacture(67226-2720)