TEATRICAL SKIN LIGHTENING SKIN LIGHTENER- hydroquinone cream

Teatrical Skin Lightening by

Drug Labeling and Warnings

Teatrical Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc., Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

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

Warnings

For external use only

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

When using this product

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

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

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

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

Directions

• ♦ 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

• ♦ Store tightly closed.
• ♦ Store at room temperature.

Inactive ingredients

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?

Call toll free 1 877 99 GENOM (43666)

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

teatrical®
Night

SKIN LIGHTENING
CREAM

Hydroquinone 2%

Lightens dark (brownish) spots
Improves skin appearance

NET WT 50 g (1.7 oz)

INGREDIENTS AND APPEARANCE

TEATRICAL SKIN LIGHTENING   SKIN LIGHTENER
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-055
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 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetyl Alcohol (UNII: 936JST6JCN)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
PEG-100 Stearate (UNII: YD01N1999R)
Propylene Glycol (UNII: 6DC9Q167V3)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polysorbate 60 (UNII: CAL22UVI4M)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Stearic Acid (UNII: 4ELV7Z65AP)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
.Beta.-Carotene (UNII: 01YAE03M7J)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-055-01	1 in 1 CARTON	10/23/2014
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	10/23/2014

Labeler - Genomma Lab USA Inc. (832323534)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(50066-055)