Label: ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C- hydroquinone emulsion

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 21, 2022

If you are a consumer or patient please visit this version.

  • DOSAGE AND ADMINISTRATION

    Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

  • WARNINGS

    Keep out of reach of children. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE

    Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

  • ACTIVE INGREDIENT

    Hydroquinone 4%

  • INACTIVE INGREDIENTS

    Ascorbic Acid, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer, Ethoxydiglycol, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Squalane, Tocopherol, Tocopheryl Acetate, Zanthoxylum Bungeanum Fruit Extract.

  • SPL UNCLASSIFIED SECTION

    Bleaches and corrects the most severe and advanced forms of hyperpigmentation in the skin with 4% hydroquinone and 20% vitamin C.

  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618
    Made in USA with US & imported materials zoskinhealth.com | 906000

  • PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton

    ZO ® SKIN HEALTH
    BY ZEIN OBAGI MD

    PIGMENT CONTROL +
    BRIGHTENING CRÈME

    4% Hydroquinone
    + 20% Vitamin C

    RX ONLY

    NDC 42851-035-81

    81 mL / 2.7 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C 
    hydroquinone emulsion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ROSEMARY (UNII: IJ67X351P9)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-035-811 in 1 CARTON05/01/2018
    181 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2018
    Labeler - ZO Skin Health, Inc. (826468527)