Label: DOUBLE FIGHT- salicylic acid and benzoyl peroxide kit
- NDC Code(s): 78863-1040-2
- Packager: Noon Aesthetics M.R. Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 12, 2023
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
- INDICATIONS & USAGE
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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.
When using this product apply
- only to areas with acne
- rinse right away with water if it gets in eyes.
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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.
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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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
DOUBLE FIGHT
salicylic acid and benzoyl peroxide kitProduct 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 creamProduct 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 creamProduct 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)
