DOUBLE FIGHT- salicylic acid and benzoyl peroxide kit

Double Fight by

Drug Labeling and Warnings

Double Fight 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

A - Therapeutic Hydrogel: Salicylic Acid 2%

B - Azelaic Cream: Benzoyl Peroxide 5%

Purpose

Acne treatment

INDICATIONS & USAGE

Use for the treatment of acne.

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne at a time.

Do not use

• on broken skin
• on large areas of the skin

When using this product apply

• only to areas with acne
• rinse right away with water if it gets in eyes.

Stop use and ask a doctor if skin irritation occurs or gets worse.

If going outside, apply sunscreen after using this product. If irritation or sensitivity develop, stop use of both products and ask doctor.

Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

Directions

Sensitivity Test for a New User: Apply products sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer of Therapeutic Hydrogel (A). After covering the affected area with Therapeutic Hydrogel, apply a thin layer of Azelaic Cream (B) Because excessive drying of the skin may occur start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness of peeling occurs, reduce application to one a day or every other day.

Inactive Ingredients

Therapeutic Hydrogel (A) Aqua, Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane ,Dimethicone, Parfum, Caprylyl Glycol, T-Butyl Alcohol, Sodium Phytate, Xhantan Gum, Sodium Hydroxide, Alcohol, Limonene.

Azelaic 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?

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

SPL UNCLASSIFIED SECTION

Developed and Dist. by
NOON Aesthetics
TLV, 62153

PRINCIPAL DISPLAY PANEL - Kit Carton

noon™

Double Fight

with DermShield™

Advanced Therapeutic
System for
Acne Treatment

A
Therapeutic
Hydrogel
Lactic Acid 10%
Salicylic Acid 2%

+

B
BenzoAzelin
Azelaic Acid 13%
Azeloglicina 10%
Benzoyl Peroxide 5%

PARACEUTICAL

50 gr / 1.76 Oz ℮

INGREDIENTS AND APPEARANCE

DOUBLE FIGHT 
salicylic acid and benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78863-1040

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-1040-2	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

SALICYLIC ACID 
salicylic acid cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.5 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
Polysorbate 20 (UNII: 7T1F30V5YH)
Propanediol (UNII: 5965N8W85T)
Water (UNII: 059QF0KO0R)
PHYTATE SODIUM (UNII: 88496G1ERL)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Strontium Chloride Hexahydrate (UNII: O09USB7Z44)
Xanthan Gum (UNII: TTV12P4NEE)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
Sodium Hydroxide (UNII: 55X04QC32I)
Cetearyl Wheat Straw Glycosides (UNII: B44PS4T8IN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
OCTYL STEARATE (UNII: 772Y4UFC8B)
Cetyl Alcohol (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Citronellyl Methylcrotonate (UNII: K61O222P3D)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)

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
OTC MONOGRAPH FINAL	part333D	01/05/2020

Part 2 of 2

BENZOYL PEROXIDE 
benzoyl peroxide cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	1.25 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, COLD PRESSED (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
OTC MONOGRAPH FINAL	part333D	01/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/05/2020

Labeler - Noon Aesthetics M.R. Ltd (600185560)

Establishment
Name	Address	ID/FEI	Business Operations
NOON Aesthetics M.R Ltd		600185560	MANUFACTURE(78863-1040)