LIGHTENER- hydroquinone cream

LIGHTENER by

Drug Labeling and Warnings

LIGHTENER by is a Otc medication manufactured, distributed, or labeled by CRC (Cosmoceutical Research Center). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

HYDROQUINONE 1.9%

PURPOSE

PURPOSE:
SKIN LIGHTENING

INDICATIONS & USAGE

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

WARNINGS

WARNING: FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

WHEN USING

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

STOP USE

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

PEDIATRIC USE

DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE.

DO NOT USE

DO NOT APPLY TO INFLAMED OR BROKEN AREA.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIGHTENER 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66538-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	1.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66538-201-12	50 g in 1 JAR; Type 0: Not a Combination Product	11/30/2011
2	NDC: 66538-201-11	30 g in 1 JAR; Type 0: Not a Combination Product	11/30/2011
3	NDC: 66538-201-13	15 g in 1 JAR; Type 0: Not a Combination Product	11/30/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	11/30/2011

Labeler - CRC (Cosmoceutical Research Center) (160019006)

Registrant - CRC (Cosmoceutical Research Center) (160019006)