ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM (HYDROQUINONE) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM (HYDROQUINONE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-032-32, 42851-033-32, 42851-185-79
Set ID 26c4c405-c698-4de4-a98f-33a29490aa0a
Category HUMAN PRESCRIPTION DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    MELAMIN™ Skin Bleaching & Correcting Crème

  • INDICATIONS & USAGE

    Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

  • DOSAGE AND ADMINISTRATION

    Apply 2 pumps (1 g) 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 afterwards.

  • 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, Brassica Oleracea Italica (Broccoli) Extract, C10-16 Alcohols, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stachys Officinalis Flower/ Leaf/Stem Extract, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

  • SPL UNCLASSIFIED SECTION

    MELAMIX™ Skin Lightener & Blending Crème

  • INDICATIONS & USAGE

    Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

  • DOSAGE AND ADMINISTRATION

    Apply 2 pumps (1 g) 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 afterwards.

  • STORAGE

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

  • ACTIVE INGREDIENT

    Hydroquinone 4%

  • INACTIVE INGREDIENTS

    Water, Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Phenoxyethanol, Ascorbic Acid, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica (Broccoli) Sprout Powder, Ascorbyl Palmitate, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stachys Officinalis Flower/Leaf/ Stem Extract, Saponins, Sodium Sulfite.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI MD

    MULTI-THERAPY HYDROQUINONE SYSTEM

    NDC 42851-185-79

    MELAMIN™ Net Wt. 32 g / 1.12 Oz.
    EXFOLIATION ACCELERATOR 30 mL / 1 Fl. Oz.
    MELAMIX™ Net Wt. 32 g / 1.12 Oz.
    DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM 
    hydroquinone kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-185
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-185-791 in 1 CARTON03/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 32 g
    Part 21 BOTTLE, PLASTIC 32 g
    Part 31 BOTTLE, PLASTIC 30 mL
    Part 41 BOTTLE, PUMP 30 mL
    Part 1 of 4
    MELAMIN SKIN BLEACHING AND CORRECTING HYDROQUINONE 
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:42851-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone0.04 g  in 1 g
    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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Tocopherol (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-032-3232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2018
    Part 2 of 4
    MELAMIX SKIN LIGHTENER AND BLENDING 
    hydroquinone cream
    Product Information
    Item Code (Source)NDC:42851-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Aminopropyl Dihydrogen Phosphate (UNII: D5J0Q2CM4V)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    BROCCOLI SPROUT (UNII: 128UH9LOAE)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)  
    Sodium Sulfite (UNII: VTK01UQK3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-033-3232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2018
    Part 3 of 4
    ZO SKIN HEALTH EXFOLIATION ACCELERATOR 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycolic Acid (UNII: 0WT12SX38S)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRPROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    INGRPropylene Glycol (UNII: 6DC9Q167V3)  
    INGRAMMONIA (UNII: 5138Q19F1X)  
    INGRCetyl Alcohol (UNII: 936JST6JCN)  
    INGRSqualane (UNII: GW89575KF9)  
    INGRSteapyrium Chloride (UNII: C9842BS3SX)  
    INGRAllantoin (UNII: 344S277G0Z)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGREthylhexylglycerin (UNII: 147D247K3P)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/01/2018
    Part 4 of 4
    ZO SKIN HEALTH DAILY POWER DEFENSE 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRCetearyl Isononanoate (UNII: P5O01U99NI)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRPentylene Glycol (UNII: 50C1307PZG)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSteareth-20 (UNII: L0Q8IK9E08)  
    INGRC14-22 Alcohols (UNII: B1K89384RJ)  
    INGRCetearyl Glucoside (UNII: 09FUA47KNA)  
    INGRC12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRRetinol (UNII: G2SH0XKK91)  
    INGR1,2-Hexanediol (UNII: TR046Y3K1G)  
    INGRHYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRMANDARIN OIL (UNII: NJO720F72R)  
    INGRLEMON OIL (UNII: I9GRO824LL)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    INGRTANGERINE (UNII: KH3E3096OO)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRFarnesol (UNII: EB41QIU6JL)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRPalmitoyl Tripeptide-1 (UNII: RV743D216M)  
    INGRPalmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRHexylene Glycol (UNII: KEH0A3F75J)  
    INGREthylhexylglycerin (UNII: 147D247K3P)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2018
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(42851-185)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.624386772MANUFACTURE(42851-185)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(42851-185)

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