Double Fight
Salicylic Acid And Benzoyl Peroxide
Noon Aesthetics M.r. Ltd
Human Otc Drug
NDC 78863-1040Double Fight also known as Salicylic Acid And Benzoyl Peroxide is a human otc drug labeled by 'Noon Aesthetics M.r. Ltd'. National Drug Code (NDC) number for Double Fight is 78863-1040. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Double Fight drug includes . The currest status of Double Fight drug is Active.
Drug Information:
| Drug NDC: | 78863-1040 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Double Fight |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Salicylic Acid And Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Noon Aesthetics M.r. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 05 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333D |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Noon Aesthetics M.R. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308693
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 78863-1040-2 | 1 BOTTLE, DISPENSING in 1 BOX (78863-1040-2) / 1 KIT in 1 BOTTLE, DISPENSING * 25 g in 1 BOTTLE, DISPENSING * 25 g in 1 BOTTLE, DISPENSING | 05 Jan, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose acne treatment
Product Elements:
Double fight salicylic acid and benzoyl peroxide salicylic acid salicylic acid salicylic acid salicylic acid polysorbate 20 propanediol water phytate sodium dimethyl sulfone strontium chloride hexahydrate xanthan gum ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) tert-butyl alcohol lactic acid, dl- sodium hydroxide cetearyl wheat straw glycosides cetostearyl alcohol isononyl isononanoate octyl stearate cetyl alcohol glyceryl monostearate peg-100 stearate phenoxyethanol caprylyl glycol citronellyl methylcrotonate cyclomethicone 5 dimethicone benzoyl peroxide benzoyl peroxide benzoyl peroxide benzoyl peroxide propanediol propylene glycol azelaic acid water sodium hydroxide alcohol alpha-arbutin dimethyl sulfone strontium chloride hexahydrate glycerin arachidyl alcohol arachidyl glucoside anhydrous dextrose glyceryl monostearate peg-100 stearate cetyl palmitate dimethyl isosorbide cetyl alcohol isononyl isononanoate phenoxyethanol caprylyl glycol docosanol cyclomethicone 5 dimethicone xylitylglucoside anhydroxylitol xylitol propolis wax citric acid monohydrate sodium benzoate potassium sorbate pummelo lemon oil, cold pressed phytate sodium potassium azeloyl diglycinate
Indications and Usage:
Use for the treatment of acne.
Warnings:
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.
Do Not Use:
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.
When Using:
When using this product apply only to areas with acne rinse right away with water if it gets in eyes.
Dosage and Administration:
Directions sensitivity test for a new user: apply products sparingly to one or two small affected areas during the ï¬rst 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.
Stop Use:
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.
Package Label Principal Display Panel:
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
Further Questions:
Questions or comments? www.noonaesthetics.com or call toll free 1-833-666-6246