DOUBLE WHITE- hydroquinone kit

Double White by

Drug Labeling and Warnings

Double White by is a Otc medication manufactured, distributed, or labeled by Noon Aesthetics M.R. Ltd, NOON Aesthetics M.R Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DOUBLE WHITE 
hydroquinone kit

Product 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) cream

Product 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 cream

Product 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)