ACCELERATED DARK SPOT CORRECTOR- hydroquinone cream 
COSMETIC ENTERPRISES LTD

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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Dark Spot Corrector

​Active Ingredients                       Purpose

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

​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. ​If product is swallowed, get medical help or contact a Poison Control Center right away. 

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

​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​​

​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.

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

SPECIFIC BEAUTY

ACCELERATE

DARK SPOT CORRECTOR

2.0% Hydroquinone Skin Lightener

0.5 FL. OZ. / 15 mL

tube

drug facts

ACCELERATED DARK SPOT CORRECTOR 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-5005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-5005-21 in 1 BOX06/12/201712/17/2021
1NDC:56152-5005-115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A06/12/201712/17/2021
Labeler - COSMETIC ENTERPRISES LTD (017701475)
Registrant - COSMETIC ENTERPRISES LTD (017701475)

Revised: 12/2021
 
COSMETIC ENTERPRISES LTD