Label: DOUBLE WHITE- hydroquinone kit
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Contains inactivated NDC Code(s)
NDC Code(s): 78863-1050-2 - Packager: Noon Aesthetics M.R. Ltd
- Category: HUMAN OTC 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 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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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.
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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.
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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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 gr Kit Carton
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INGREDIENTS AND APPEARANCE
DOUBLE WHITE
hydroquinone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78863-1050 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78863-1050-2 1 in 1 BOX 01/05/2020 1 1 in 1 BOTTLE, DISPENSING Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, DISPENSING 25 g Part 2 1 BOTTLE, DISPENSING 25 g Part 1 of 2 VIT C SERUM
face and neck (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Propanediol (UNII: 5965N8W85T) INGR Propylene Glycol (UNII: 6DC9Q167V3) INGR Alcohol (UNII: 3K9958V90M) INGR Phytate Sodium (UNII: 88496G1ERL) INGR Citric Acid Monohydrate (UNII: 2968PHW8QP) INGR Cyclomethicone 5 (UNII: 0THT5PCI0R) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR Isononyl Isononanoate (UNII: S4V5BS6GCX) INGR Prunus Armeniaca Seed (UNII: 75356789IW) INGR Ascorbyl Glucoside (UNII: 2V52R0NHXW) INGR Phenoxyethanol (UNII: HIE492ZZ3T) INGR Trisodium Citrate Dihydrate (UNII: B22547B95K) INGR Potassium Hydroxide (UNII: WZH3C48M4T) INGR Xanthan Gum (UNII: TTV12P4NEE) INGR Caprylyl Glycol (UNII: 00YIU5438U) INGR Medium-Chain Triglycerides (UNII: C9H2L21V7U) INGR Squalane (UNII: GW89575KF9) INGR .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) INGR Ascorbyl Tetraisopalmitate (UNII: 47143LT58A) INGR Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L) INGR Ethylhexyl Cocoate (UNII: I1MPW273QS) INGR PPG-3 benzyl ether myristate (UNII: 8075L58MKO) INGR Polysorbate 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 25 g in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/05/2020 Part 2 of 2 AZEWHITE CREAM
hydroquinone creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 0.5 g in 25 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 25 g in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/05/2020 Labeler - Noon Aesthetics M.R. Ltd (600185560) Establishment Name Address ID/FEI Business Operations NOON Aesthetics M.R Ltd 600185560 MANUFACTURE(78863-1050)