MD ACNE MEDICATED DARK SPOT REMOVER- hydroquinone cream

MD Acne Medicated Dark Spot Remover by

Drug Labeling and Warnings

MD Acne Medicated Dark Spot Remover by is a Otc medication manufactured, distributed, or labeled by MD Algorithms Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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:

INGREDIENTS AND APPEARANCE

MD ACNE MEDICATED DARK SPOT REMOVER 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-231-03	90 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	06/01/2018

Labeler - MD Algorithms Inc. (080479826)