DOUBLE FIGHT- salicylic acid and benzoyl peroxide 
Noon Aesthetics M.R. Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Double Fight

Drug Facts:

Active Ingredients

A - Therapeutic Hydrogel: Salicylic Acid 2%

B - Azelaic Cream: Benzoyl Peroxide 5%

Purpose

Acne treatment

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

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 ℮

PRINCIPAL DISPLAY PANEL - Kit Carton
DOUBLE FIGHT 
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1040
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78863-1040-21 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
SALICYLIC ACID 
salicylic acid cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.5 g  in 25 g
Inactive Ingredients
Ingredient NameStrength
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 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
OTC MONOGRAPH FINALpart333D01/05/2020
Part 2 of 2
BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide1.25 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, COLD PRESSED (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
OTC MONOGRAPH FINALpart333D01/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/05/2020
Labeler - Noon Aesthetics M.R. Ltd (600185560)
Establishment
NameAddressID/FEIBusiness Operations
NOON Aesthetics M.R Ltd600185560MANUFACTURE(78863-1040)

Revised: 1/2023
Document Id: d8a988e2-267a-4f33-8d35-b3ddb0ab43fb
Set id: 1fb83be2-6140-45e8-a95f-188f147a038d
Version: 2
Effective Time: 20230112
 
Noon Aesthetics M.R. Ltd