FDA.reportPublic FDA data

Teatrical ® Skin Lightening Cream

Manufacturer
Genomma Lab USA Inc. | Garcoa, Inc.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:42:26

Label at a glance#

ProductTeatrical Skin Lightening Skin Lightener
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 usi...

Storage and handling

♦ Store 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 discoloration 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 ask 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

  • Store 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, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

teatrical®
Night

SKIN LIGHTENING
CREAM

Hydroquinone 2%

Lightens dark (brownish) spots
Improves skin appearance

NET WT 50 g (1.7 oz)

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-05550066-055-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydroquinoneXV74C1N1AEACTIB
Water059QF0KO0RIACT
Mineral OilT5L8T28FGPIACT
Glyceryl Monostearate230OU9XXE4IACT
Cetyl Alcohol936JST6JCNIACT
Isopropyl Myristate0RE8K4LNJSIACT
PEG-100 StearateYD01N1999RIACT
Propylene Glycol6DC9Q167V3IACT
Cetostearyl Alcohol2DMT128M1SIACT
Polysorbate 60CAL22UVI4MIACT
Sodium Metabisulfite4VON5FNS3CIACT
Stearic Acid4ELV7Z65APIACT
.Alpha.-Tocopherol Acetate, DL-WR1WPI7EW8IACT
.Beta.-Carotene01YAE03M7JIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
Iodopropynyl Butylcarbamate603P14DHEBIACT

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
4304aa9e-3c28-43d1-81b0-ec5fb4d995ebbf642c92-e75a-4f66-a501-2997232ba86f2022-09-20WarningsExact identifier
spl set id: bf642c92-e75a-4f66-a501-2997232ba86f

Reported adverse events (FAERS/openFDA)#

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