DARK SPOT LIGHTENING CREAM- hydroquinone cream

Dark Spot Lightening Cream by

Drug Labeling and Warnings

Dark Spot Lightening Cream by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Hydroquinone 2% Skin lightener

PURPOSE

Use

Lightens dark (brownish) discolorations in the skin such as: freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if

• Skin irritation becomes severe or allergic reaction occurs such as hives, itching, or wheezing

WARNINGS

Warnings

For external use only

Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing as severe asthma attack in certain susceptible persons.

Do not use on children under 12 years of age unless directed by a doctor

When using this product

• avoid contact with eyes
• some users may experience a mild skin irritatiion\

Sunburn alert: This product may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

If pregnant or breast-feeding, ask a doctor before use.

DOSAGE & ADMINISTRATION

Directions

• Adults: apply a small amount as a thin layer on the affected area in the evening, or use as directed by a doctor. If no improvement is seen in 3 months of treatment, use of this product should be discontinued. Lightening effect of this product might not be noticeable when used on very dark skin.
• Children under 12 years of age: do not use unless directed by a doctor.
• Sun Exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

INACTIVE INGREDIENT

Water (Aqua), Glycolic Acid, Glyceryl Stearate, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Propanediol, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Phenoxyethanol, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xantan Gum, Allantoin, Ferulic Acid, Ethylhexylglycerin, Dipotassium Glycyrrhizate

PRINCIPAL DISPLAY PANEL

Dark Spot Lightening Cream

2% Hydroquinone

6% Glycolic Acid

1.7 FL OZ 50mL

INGREDIENTS AND APPEARANCE

DARK SPOT LIGHTENING CREAM 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-4002
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SODIUM SULFATE (UNII: 0YPR65R21J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-40 STEARATE (UNII: ECU18C66Q7)
FERULIC ACID (UNII: AVM951ZWST)
ALLANTOIN, (+)- (UNII: XDK458E1J9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-4002-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	12/21/2018

Labeler - Cosmetic Enterprises Ltd. (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd.		217269489	manufacture(56152-4002)