Accelerated Dark Spot Corrector: Package Insert and Label Information

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.

​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
(click image for full-size original)
drug facts
(click image for full-size original)
ACCELERATED DARK SPOT CORRECTOR
hydroquinone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-5005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALKYL (C12-15) BENZOATE
BUTYLENE GLYCOL
DIETHYLENE GLYCOL MONOETHYL ETHER
STEARYL ALCOHOL
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
PANTHENOL
ALLANTOIN
DIMETHICONE
SQUALENE
STEARETH-21
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
POLYSORBATE 60
STEARETH-2
PHENOXYETHANOL
SODIUM BISULFITE
SORBIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56152-5005-2 1 TUBE in 1 BOX contains a TUBE (56152-5005-1)
1 NDC:56152-5005-1 15 mL in 1 TUBE This package is contained within the BOX (56152-5005-2)
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 Operations
COSMETIC ENTERPRISES LTD 017701475 manufacture (56152-5005)

Revised: 06/2017 COSMETIC ENTERPRISES LTD

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