Label: DOUBLE WHITE- hydroquinone kit

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

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Drug Label Information

Updated April 12, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients

    Hydroquinone 2%

  • Purpose

    Skin Bleaching

  • Uses

    For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin.

  • 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.
    • 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.

    • Keep out of reach of children.
    • If swallowed, seek 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.

  • Directions

    Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer of Vit C Serum 11S (A). After covering the affected area with Vit C Serum 11S, apply a thin layer of AzeWhite Cream (B). Apply one or two times daily, if bothersome dryness of peeling occurs, reduce application to one a day or every other day.

  • Inactive Ingredients

    Vit C Serum 11 S (A)

    Aqua, Ascorbyl Tetrasoilpalmitate, Isononyl Isononoate, Ascorbyl Glucoside, Propanediol, Caprylic Triglyceride, Squalane , Plankton Extract, Prunus Armeniaca (Apricot) Kernel Oil, Phenoxyethanol, Potassium Hydroxide, Dimethicone, Trisodium Citrate Dihydrate, PPG-3 Benzyl Ether Myristate, Xanthan Gum, Tocopheryl Acetate , Ethylhexyl Cocoate, Sodium Polyacrylate, Caprylyl Glycol, Citric Acid, Propylene Glycol, Sodium Phytate, Cyclopentasiloxane, Polysorbate 20, Alcohol.

    AzeWhite Cream (B)

    Aqua, Azelaic Acid, Azeloglicina , Propylene Glycol, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Alpha-Arbutin, Isononyl Isononanoate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Dimethyl Isosorbide, Sodium Hydroxide, Cetyl Palmitate, Phenoxyethanol, Xylitol, Dimethicone, Anhydroxylitol, Arachidyl Alcohol, Cetyl Alcohol, Behenyl Alcohol, Xylitylglucoside, Parfum, Citrus Limon Peel Oil, Arachidyl Glucoside, Caprylyl Glycol, Sodium Phytate, Propolis Extract, Glucose, Citric Acid, Sodium Benzoate, Potassium Sorbate, Alcohol.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Visit www. noonaesthetics. com
    or call Toll Free 1-833-666-6246

  • SPL UNCLASSIFIED SECTION

    Developed and Dist. by
    NOON Aesthetics
    TLV,,62153 , Made in Israel

  • PRINCIPAL DISPLAY PANEL - 50 gr Kit Carton

    NOON™

    Double White

    with DermShield ™

    Advanced
    Intensive System
    for Comprehensive
    Whitening Treatment

    A
    Vit C
    Serum 11S
    Stable 11% Vitamin C
    Plankton Extract

    +

    B
    AzeWhite
    Cream
    Azelaic Acid 13%
    Derivative of Az. Acid 10%
    Alpha Arbutin 5%
    Hydroquinone 2%

    PARACEUTICAL

    50 gr / 1.76 Oz e

    Principal Display Panel - 50 gr Kit Carton
  • INGREDIENTS AND APPEARANCE
    DOUBLE WHITE 
    hydroquinone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1050
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1050-21 in 1 BOX01/05/2020
    11 in 1 BOTTLE, DISPENSING
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DISPENSING 25 g
    Part 21 BOTTLE, DISPENSING 25 g
    Part 1 of 2
    VIT C SERUM 
    face and neck (excluding shaving preparations) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPropanediol (UNII: 5965N8W85T)  
    INGRPropylene Glycol (UNII: 6DC9Q167V3)  
    INGRAlcohol (UNII: 3K9958V90M)  
    INGRPhytate Sodium (UNII: 88496G1ERL)  
    INGRCitric Acid Monohydrate (UNII: 2968PHW8QP)  
    INGRCyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRIsononyl Isononanoate (UNII: S4V5BS6GCX)  
    INGRPrunus Armeniaca Seed (UNII: 75356789IW)  
    INGRAscorbyl Glucoside (UNII: 2V52R0NHXW)  
    INGRPhenoxyethanol (UNII: HIE492ZZ3T)  
    INGRTrisodium Citrate Dihydrate (UNII: B22547B95K)  
    INGRPotassium Hydroxide (UNII: WZH3C48M4T)  
    INGRXanthan Gum (UNII: TTV12P4NEE)  
    INGRCaprylyl Glycol (UNII: 00YIU5438U)  
    INGRMedium-Chain Triglycerides (UNII: C9H2L21V7U)  
    INGRSqualane (UNII: GW89575KF9)  
    INGR.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    INGRAscorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    INGRSodium Polyacrylate (8000 MW) (UNII: 285CYO341L)  
    INGREthylhexyl Cocoate (UNII: I1MPW273QS)  
    INGRPPG-3 benzyl ether myristate (UNII: 8075L58MKO)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    125 g in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/05/2020
    Part 2 of 2
    AZEWHITE CREAM 
    hydroquinone cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone0.5 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    Propanediol (UNII: 5965N8W85T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Azelaic Acid (UNII: F2VW3D43YT)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Alcohol (UNII: 3K9958V90M)  
    Alpha-Arbutin (UNII: 72VUP07IT5)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Strontium Chloride Hexahydrate (UNII: O09USB7Z44)  
    Glycerin (UNII: PDC6A3C0OX)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Anhydrous Dextrose (UNII: 5SL0G7R0OK)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Docosanol (UNII: 9G1OE216XY)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Xylitylglucoside (UNII: O0IEZ166FB)  
    Anhydroxylitol (UNII: 8XWR7NN42F)  
    Xylitol (UNII: VCQ006KQ1E)  
    Propolis Wax (UNII: 6Y8XYV2NOF)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Pummelo (UNII: ET1TN5W71X)  
    Lemon Oil (UNII: I9GRO824LL)  
    Phytate Sodium (UNII: 88496G1ERL)  
    Potassium Azeloyl Diglycinate (UNII: N02RVN6NYP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    125 g in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/05/2020
    Labeler - Noon Aesthetics M.R. Ltd (600185560)
    Establishment
    NameAddressID/FEIBusiness Operations
    NOON Aesthetics M.R Ltd600185560MANUFACTURE(78863-1050)
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