Label: DR. LIGHTENING ULTRA-POTENT FACIAL- hydroquinone cream

  • NDC Code(s): 63742-025-01
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 30, 2019

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  • DRUG FACTS

  • Active Ingredient

    Hydroquinone 2%

    Purpose

    Skin Lightener

  • Uses:

    for the gradual fading of hyperpigmentation spots.

  • Warnings:

    For external use only

    When using this product

    • avoid contact with eyes.
    • some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a doctor.
    • for external use only.

    for external use only.

    • if skin irritation becomes severe.

    if pregnant or breastfeeding,

    • consult a doctor before use.

    Do not use this product if

    children under 12 years of age, unless directed by a doctor

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

    Sunburn Alert
    The Alpha and Beta Hydroxy Acids (AHA/BHA)in this product may increase sun sensitivity. Wear sunscreen or protective clothing during use to protect against sunburn and for a week afterwards. Continue sun protection after the lightening regimen to avoid UV-induced pigmentations.

  • Directions

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

    store at 20°-25° C (68-77° F)

  • Inactive Ingredients

    Arbutin, Arginine, Azelaic Acid, Carrageenan, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethyl Isosorbide, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Polydecene, Isododecane, Kojic Acid, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Purified Water, Salicylic Acid, Sodium Benzoate, Sodium  Polyacrylate, Sodium Sulfite, Trideceth-6

  • Questions or comments?

    Call toll free 1(844) 694-0004

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DR. LIGHTENING ULTRA-POTENT FACIAL 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ARBUTIN (UNII: C5INA23HXF)  
    ARGININE (UNII: 94ZLA3W45F)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    ISODODECANE (UNII: A8289P68Y2)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-025-0144 g in 1 TUBE; Type 0: Not a Combination Product02/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A02/15/2019
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
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