MD ACNE MEDICATED DARK SPOT REMOVER- hydroquinone cream 
MD Algorithms Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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MD-Acne Medicated Dark Spot Remover

DRUF FACTS:

Active Ingredient:

Hydroquinone 2.00%

Skin Lightener

Use For:

Lightens dark spots in the skin such as post acne brown spots and age spots.

Warnings:

  • For external use only.
  • Avoid contact with eyes or eyelids.
  • Some users of this product may experience mild skin irritation.
  • Consult physician if skin irritation becomes severe.

Do not use

on children under 12, unless directed by physician.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Store at room temperature.

Directions:

Adults: Apply a thin layer on the affected areas twice daily, or as directed by physician.

  • If no improvement is seen after three months of treatment, discontinue use of this product and consults physician.
  • Lightening effect of this product may be less noticeable on very dark skin.
  • Children under 12-years of age: Do not use this product unless directed by physician
  • Sun exposure should be limited by using sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using, and after using this product, in order to prevent darkening from reoccurring.

Other Ingredient:

Aqua (Deionized Water), Ascorbic Acid (vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Parfum (Fragrance), PEG 150 Distearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Steareth-2, Steareth-20, Tetrasodium

Package Labeling:

Label2

MD ACNE MEDICATED DARK SPOT REMOVER 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CUCUMBER (UNII: YY7C30VXJT)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARETH-23 (UNII: N1C835P33B)  
STEARETH-20 (UNII: L0Q8IK9E08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71804-231-0390 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201809/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/201809/30/2022
Labeler - MD Algorithms Inc. (080479826)

Revised: 10/2023
 
MD Algorithms Inc.