ACTIVATOR 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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Activator Light

Active Ingredient


Hydroquinone USP (2%)

Indication

Skin Lightening

Indication

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.

Precautions

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.

Precautions

keep out of reach of children

Directions

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).

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.

Principal Display Panel

ActivatorLight_PackageLabel_PrincipalDisplayPanel

ACTIVATOR LIGHT 
hydroquinone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2720
Route of Administration TOPICAL DEA Schedule     
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
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)  
TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
WATER (UNII: 059QF0KO0R)  
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)

Revised: 11/2013
Document Id: 06d2f445-cbcb-42d6-89ac-7ac89ef85093
Set id: f3ba89a8-cd4e-43e3-bfd6-d5575bdf9029
Version: 2
Effective Time: 20131106
 
Vivier Pharma, Inc.