Teatrical ® Pro-Aclarant Skin Lightening Cream

Manufacturer
Genomma Lab USA
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:32

Label at a glance#

ProductTeatrical Pro-Aclarant Skin Lightening
Active ingredientHydroquinone
Label structure11 sections

Dosage and administration

Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin. Children under 12 years of age: Do not use unless directed by a doctor. Exposure to the sun should be limited by using a s...

Storage and handling

Keep tightly closed. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Use

INDICATIONS & USAGE SECTION

Lightens dark (brownish) spots, blotches, freckles and discolorations of the skin.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • you may experience mild skin irritation
  • avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and consult a doctor if skin irritation becomes severe.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 12 years of age: Do not use unless directed by a doctor.
  • Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.

Other information

STORAGE AND HANDLING SECTION

  • Keep tightly closed.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragance

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-994-3666

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston,
TX 77027

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

teatrical®

PRO-ACLARANT
SKIN LIGHTENING

NIGHT
CREAM

HYDROQUINONE 2%

Lightens dark spots

NET WT 1.7 OZ (48 g)

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-072-012022-01-28C16284748780-1d6a99b39-55d3-a426-e053-dadaa90af4c2Teatrical ® Pro-Aclarant Skin Lightening Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-072-01Teatrical Pro-Aclarant Skin Lightening48 g in 1 TUBECREAM481
50066-072-01Teatrical Pro-Aclarant Skin Lightening1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-072TEATRICAL PRO-ACLARANT SKIN LIGHTENING (HYDROQUINONE) CREAM [GENOMMA LAB USA]1Legacy NDC, 2 package rows20200423_c20869a0-1b14-4df5-aeab-ce9c85513141.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-07250066-072-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
975473b0-1767-4756-9fab-bc36d38db0b5c20869a0-1b14-4df5-aeab-ce9c855131412020-04-22WarningsExact identifier
spl id: 975473b0-1767-4756-9fab-bc36d38db0b5
spl set id: c20869a0-1b14-4df5-aeab-ce9c85513141

Reported adverse events (FAERS/openFDA)#

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