ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]
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NDC 42851-037-30, 42851-037-80
Set ID 83e34a75-d20c-43ab-be31-f8fcafec46d0
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. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. 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.

  • SUNBURN ALERT

    This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

  • STORAGE

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

  • ACTIVE INGREDIENT

    Hydroquinone 4%

  • INACTIVE INGREDIENTS

    Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, 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.

  • 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

    PIGMENT CONTROL
    CRÈME

    4% Hydroquinone

    RX ONLY

    NDC 42851-037-80

    80 mL / 2.7 Fl. Oz.

    Principal Display Panel - 80 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
    hydroquinone emulsion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone40 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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    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:42851-037-801 in 1 CARTON04/15/2018
    180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:42851-037-301 in 1 CARTON07/01/2018
    230 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 other04/15/2018
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046ANALYSIS(42851-037) , LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation080095015LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037)

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