Label: DERMA LIGHTENING- hydroquinone, tretinoin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 1, 2021

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  • 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

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    DERMA LIGHTENING 
    hydroquinone, tretinoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE6 mg  in 30 g
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.075 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-412-011 in 1 CARTON12/24/2014
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/24/2014
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)
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