FDA.reportPublic FDA data

MD Acne Medicated Dark Spot Remover

Manufacturer
MD Algorithms Inc.
Effective date
2022-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:03:25

Label at a glance#

ProductMD Acne Medicated Dark Spot Remover
Active ingredientHYDROQUINONE
Label structure7 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2.00%

OTC - PURPOSE SECTION

Skin Lightener

Use For:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • 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

OTC - DO NOT USE SECTION

on children under 12, unless directed by physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact physician or poison control center immediately.

SPL UNCLASSIFIED SECTION

Store at room temperature.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-23171804-231-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
LICORICE61ZBX54883IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
STEARETH-23N1C835P33BIACT
STEARETH-20L0Q8IK9E08IACT
HYDROQUINONEXV74C1N1AEACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07925f02-44f4-f1c8-e063-6394a90a25acd79d831c-e5ee-47db-b73a-573250d9dd3c2023-10-13WarningsExact identifier
spl set id: d79d831c-e5ee-47db-b73a-573250d9dd3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.