Label: ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE- hydroquinone lotion

  • Category: HUMAN OTC DRUG LABEL

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 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydroquinone, 2%

  • Purpose

    Skin Lightener

  • Uses

    For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

  • Warnings

    For external use only.

    Avoid contact with eyes.

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

    Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

    Keep out of reach of children.

    If swallowed, seek 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.
    • Sun exposure should be limited by using a sunscreen 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 a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
  • Inactive Ingredients

    Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract

  • Questions?

    5 Technology Dr. Irvine, CA 92618

  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

    ZO ® SKIN HEALTH
    BY ZEIN OBAGI MD

    NDC 42851-039-80

    PIGMENT CONTROL +
    BLENDING CRÈME
    2% Hydroquinone

    80 mL / 2.7 Fl. Oz.

    Principal Display Panel - 80 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-039-801 in 1 CARTON01/11/201909/23/2020
    180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/11/2019
    Labeler - ZO Skin Health, Inc. (826468527)