ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]
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NDC 42851-035-81
Set ID d7bfa71b-ddce-437e-abf9-2837af82c54d
Category HUMAN PRESCRIPTION DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046ANALYSIS(42851-035) , LABEL(42851-035) , MANUFACTURE(42851-035) , PACK(42851-035) , RELABEL(42851-035) , REPACK(42851-035)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation080095015LABEL(42851-035) , MANUFACTURE(42851-035) , PACK(42851-035) , RELABEL(42851-035) , REPACK(42851-035)

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