LIGHTENER- hydroquinone cream 
CRC (Cosmoceutical Research Center)

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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ACTIVE INGREDIENT:

HYDROQUINONE 1.9%

PURPOSE:
SKIN LIGHTENING

INDICATION:
FOR GRADUAL FADING OF FRECKLES AND AGE SPOTS.
HELPS SKIN DISCOLORATION THAT MAY RESULT FROM PREGNANCY OR USE OF ORAL CONTRACEPTIVE.

WARNING: FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS: A THIN LAYER SHOULD BE APPLIED TO THE ENTIRE FACE TWICE DAILY OR AS DIRECTED.

INACTIVE INGREDIENTS: PURIFIED WATER, SAFFLOWER OIL, PHOSPHOLIPIDS, ISOPROPYL PALMITATE, ETHOXYDIGLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, XANTHAN GUM, LACTIC ACID, TETRAHEXYLDECYL ASCORBATE, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, METHYLISOTHIAZOLINONE, SODIUM BICARBONATE, BUTYLENE GLYCOL, SODIUM METABISULFITE, LICORICE EXTRACT, METHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN.

DURING AND AFTER TREATMENT EXPOSURE TO SUN MUST BE AVOIDED BY SUNSCREEN USAGE OR PROTECTIVE CLOTHING.

IF NO BLEACHING IS NOTICED AFTER 3 MONTHS, STOP TREATMENT.

DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE.

DO NOT APPLY TO INFLAMED OR BROKEN AREA.

Lightener Box

LIGHTENER 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66538-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LACTIC ACID (UNII: 33X04XA5AT)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66538-201-1250 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
2NDC:66538-201-1130 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
3NDC:66538-201-1315 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A11/30/2011
Labeler - CRC (Cosmoceutical Research Center) (160019006)
Registrant - CRC (Cosmoceutical Research Center) (160019006)

Revised: 2/2019
 
CRC (Cosmoceutical Research Center)