Eradikate Acne Mark Fading
Salicylic Acid
Kate Somerville Skincare, Llc
Human Otc Drug
NDC 43479-112Eradikate Acne Mark Fading also known as Salicylic Acid is a human otc drug labeled by 'Kate Somerville Skincare, Llc'. National Drug Code (NDC) number for Eradikate Acne Mark Fading is 43479-112. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Eradikate Acne Mark Fading drug includes Salicylic Acid - 2 g/100mL . The currest status of Eradikate Acne Mark Fading drug is Active.
Drug Information:
| Drug NDC: | 43479-112 |
| 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: | Eradikate Acne Mark Fading |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kate Somerville Skincare, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | SALICYLIC ACID - 2 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 01 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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, 2023 |
| 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: | KATE SOMERVILLE SKINCARE, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 346298
|
| 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: | O414PZ4LPZ
|
| 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 |
|---|
| 43479-112-51 | 1 BOTTLE in 1 BOX (43479-112-51) / 30 mL in 1 BOTTLE | 01 Apr, 2021 | 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:
Eradikate acne mark fading salicylic acid water coconut alkanes pentylene glycol niacinamide caprylyl trisiloxane glycerin cetearyl olivate dimethicone/vinyl dimethicone crosspolymer (soft particle) potassium cetyl phosphate sorbitan olivate carbomer homopolymer, unspecified type microcitrus australis fruit lentil apple watermelon eremocitrus glauca fruit sodium lactate phytosphingosine adenosine decyl glucoside 1,2-hexanediol sodium pyrrolidone carboxylate .alpha.-glucan oligosaccharide maltodextrin polyglyceryl-3 caprate butylene glycol aminomethylpropanol polysorbate 20 caprylhydroxamic acid zinc pidolate thymol terpineol hexylene glycol caprylyl glycol polydextrose icodextrin amylopectin, unspecified source lactobacillus reuteri phenoxyethanol edetate disodium sodium benzoate potassium sorbate salicylic acid salicylic acid
Indications and Usage:
Uses for the treatment of acne helps keep skin clear of new acne blemishes
Warnings:
Warnings for external use only when using this product skin irritation or dryness is more likely to occur if you use another topical acne medicationat the same time. if irritation occurs, only use one topical acne medication at a time.
Dosage and Administration:
Directions am and pm. apply to targeted areas or all over a cleansed and dried face, avoiding eye area. allow to fully absorb into the skin. because excessive drying of the skin make 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 or peeling occurs, reduce application to once a day or every other day.
Package Label Principal Display Panel:
01b uc_eradikate acne fading gel
Further Questions:
Questions? visit www.katesomerville.com or call 1-800-984-5283.