Dark Spot Lightening Cream

Manufacturer
Cosmetic Enterprises Ltd.
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:13

Label at a glance#

ProductDark Spot Lightening Cream
Active ingredientHYDROQUINONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Hydroquinone 2% Skin lightener

OTC - PURPOSE SECTION

Use

Lightens dark (brownish) discolorations 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if

  • Skin irritation becomes severe or allergic reaction occurs such as hives, itching, or wheezing

WARNINGS SECTION

Warnings

For external use only

Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing as severe asthma attack in certain susceptible persons.

Do not use on children under 12 years of age unless directed by a doctor

When using this product

  • avoid contact with eyes
  • some users may experience a mild skin irritatiion\

Sunburn alert: This product may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

If pregnant or breast-feeding, ask a doctor before use.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: apply a small amount as a thin layer on the affected area in the evening, or use as directed by a doctor. If no improvement is seen in 3 months of treatment, use of this product should be discontinued. Lightening effect of this product might not be noticeable when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun Exposure 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.

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycolic Acid, Glyceryl Stearate, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Propanediol, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Phenoxyethanol, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xantan Gum, Allantoin, Ferulic Acid, Ethylhexylglycerin, Dipotassium Glycyrrhizate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dark Spot Lightening Cream

2% Hydroquinone

6% Glycolic Acid

1.7 FL OZ 50mL

boxbox

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
153031hydroquinone 2 % Topical CreamPSN1
153031hydroquinone 20 MG/ML Topical CreamSCD1
153031hydroquinone 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56152-4002-12021-01-29C16284748780-1ba0f9c33-2e4d-a910-e053-dadaa90a0b85Dark Spot Lightening Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56152-4002-1Dark Spot Lightening Cream50 mL in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56152-4002DARK SPOT LIGHTENING CREAM (HYDROQUINONE) CREAM [COSMETIC ENTERPRISES LTD.]1Legacy NDC, 1 package rows20190117_7d8d68c1-a16b-29d3-e053-2991aa0a0563.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56152-400256152-4002-1

Ingredients#

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

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

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
7d8d68c1-a16c-29d3-e053-2991aa0a05637d8d68c1-a16b-29d3-e053-2991aa0a05632018-12-21WarningsExact identifier
spl id: 7d8d68c1-a16c-29d3-e053-2991aa0a0563
spl set id: 7d8d68c1-a16b-29d3-e053-2991aa0a0563

Reported adverse events (FAERS/openFDA)#

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