Asepxia Oil-free Acne Bar
Salicylic Acid
Genomma Lab Usa
Human Otc Drug
NDC 50066-803Asepxia Oil-free Acne Bar also known as Salicylic Acid is a human otc drug labeled by 'Genomma Lab Usa'. National Drug Code (NDC) number for Asepxia Oil-free Acne Bar is 50066-803. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Asepxia Oil-free Acne Bar drug includes Salicylic Acid - 2 g/100g . The currest status of Asepxia Oil-free Acne Bar drug is Active.
Drug Information:
| Drug NDC: | 50066-803 |
| 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: | Asepxia Oil-free Acne Bar |
| 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: | Genomma Lab Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Soap |
| 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/100g
|
| 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: | 19 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | Genomma Lab USA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312882
2000543
|
| 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 |
|---|
| 50066-803-01 | 1 APPLICATOR in 1 CARTON (50066-803-01) / 113 g in 1 APPLICATOR | 19 Mar, 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:
Asepxia oil-free acne bar salicylic acid sodium palmate sodium cocoate sodium palm kernelate water glycerin sodium chloride sulfur sodium hydroxide edetate sodium pentasodium pentetate glycolic acid titanium dioxide butylated hydroxytoluene fd&c yellow no. 5 citric acid monohydrate edetate disodium anhydrous opuntia ficus-indica stem fd&c yellow no. 6 ferric oxide red salicylic acid salicylic acid asepxia
Indications and Usage:
Uses for the treatment of acne reduces the number of acne pimples allows skin to heal penetrates pores to clear most acne blemishes dries up acne pimples helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads
Warnings:
Warnings for external use only when using this product , skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. if this occurs, use only one medication at a time unless directed by a doctor. avoid contact with eyes. if product gets in eyes, rinse with water. stop use and ask a doctor if excessive skin irritation occurs keep out of reach of children . if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product , skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. if this occurs, use only one medication at a time unless directed by a doctor. avoid contact with eyes. if product gets in eyes, rinse with water.
Dosage and Administration:
Directions apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne. rinse thoroughly and pat dry with a clean towel. if bothersome dryness or peeling occurs, reduce application to every other day.
Stop Use:
Stop use and ask a doctor if excessive skin irritation occurs
Package Label Principal Display Panel:
Principal display panel - 113 g bar carton new formula oily skin with imperfections asepxia ® with hydro-force⢠acne bar soap oil-free deep cleansing anti-sebum 2% salicylic acid enriched with a touch of sulfur* > oil skin control > deeply cleans and exfoliates without overdrying net wt. 4 oz (113 g) principal display panel - 113 g bar carton
Further Questions:
For more product information, please call toll free: 1 877 99 genom (43666)