DERMA LIGHTENING- hydroquinone, tretinoin cream

Derma Lightening by

Drug Labeling and Warnings

Derma Lightening by is a Otc medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Forms and Presentation

Cream: Tube of 30 g.

Active Ingredients

Hydroquinone 2%

Tretinoin 0.025%

Inactive Ingredients

Aqua, Glycerin, Cetyl Alcohol, Ceteareth- 25, Cetearyl Alcohol, Caprylic / Capric Triglyceride, Dimethicone, Stearic Acid, Petrolatum, Benzyl Alcohol, Sodium Lauryl Sulphate, Potassium Sorbate, Sodium Metabisulfite, Parfum and BHA

Purpose

Lightening Cream

Properties

Night cream that lightens and moisturizes the skin.
Paraben free.

Indications

Whitening of skin.
Reduction of spots due to sunlight exposure.
Pregnancy Mask (Melasma). (Use after pregnancy)
Reduction of secular pigmentations of acne.
Can be used on knees and elbows.

Precaution

keep out of reach of children

Warnings

• For external use only
• Avoid contact with eyes
• Do not expose to sunlight and wear protective clothing

Contraindications

Hypersensitivity to any of the components.

Side effects

There are no known side effects.

Dosage and administration

Apply the cream once daily at night after cleansing. Then rub it gently.

Storage conditions

Store at a temperature be]ow 30 °C.
Do not store after a month from opening the tube.

Primary Package

Secondary Package

INGREDIENTS AND APPEARANCE

DERMA LIGHTENING 
hydroquinone, tretinoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	6 mg  in 30 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	0.075 mg  in 30 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
DIMETHICONE 100 (UNII: RO266O364U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARETH-25 (UNII: 8FA93U5T67)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-412-01	1 in 1 CARTON	12/24/2014
1		30 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
unapproved drug other		12/24/2014

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)