ACCELERATED DARK SPOT CORRECTOR- hydroquinone cream

Accelerated Dark Spot Corrector by

Drug Labeling and Warnings

Accelerated Dark Spot Corrector 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 Ingredients                       Purpose

Hydroquinone 2.0% .................... Skin Lightener

PURPOSE

​Uses

• ​lightens dark spots 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 product is swallowed, get medical help or contact a Poison Control Center right away. 

INDICATIONS & USAGE

​Stop use and ask a doctor if ​skin rash occurs

WARNINGS

​Warnings

For external use only

When using this product

• avoid direct contact with eyes
• some users of this product may experience a mild skin irritation
• if skin irritation becomes severe, stop use and consult a physician
• do not use on children under 12 years of age unless directed by a physician
• sun exspoure 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
• avoid overuse of hydroquinone which has been associated with a rare skin condition called ochronosis​​

DOSAGE & ADMINISTRATION

​Directions​

• adults apply a small amount as a thin layer over face, neck, and chest in the evening, or use as directed by a physician
• if no improvement is seen after three months of treatment, use of this product should be discontinued
• lightening effect of this product many not be noticeable when used on very dark skin
• for children under 12 years of age, do not use unless directed by a physician.

INACTIVE INGREDIENT

Water (Aqua). C12-15 Alkyl Benzoate, Butylene Glycol, Ethoxydiglycol, Stearyl Alcohol, Glyceryl Stearate, Cetyl Alcohol, Tocopheryl Acetate, Panthenol, Allantoin, Dimethicone, Squalane, Steareth-21, Hydroxyethyl Acrylate/Sodium Acryloyldiemthyl Taurate Crosspolymer, Polysorbate 60, Steareth-2, Phenoxyethanol, Sodium Bisulfite, Sorbic Acid, Citric Acid, Disodium EDTA

PRINCIPAL DISPLAY PANEL

SPECIFIC BEAUTY

ACCELERATE

DARK SPOT CORRECTOR

2.0% Hydroquinone Skin Lightener

0.5 FL. OZ. / 15 mL

INGREDIENTS AND APPEARANCE

ACCELERATED DARK SPOT CORRECTOR 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5005
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
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
SQUALENE (UNII: 7QWM220FJH)
STEARETH-21 (UNII: 53J3F32P58)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-2 (UNII: V56DFE46J5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BISULFITE (UNII: TZX5469Z6I)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5005-2	1 in 1 BOX	06/12/2017
1	NDC: 56152-5005-1	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	06/12/2017

Labeler - COSMETIC ENTERPRISES LTD (017701475)

Registrant - COSMETIC ENTERPRISES LTD (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC ENTERPRISES LTD		017701475	manufacture(56152-5005)