Thera Wise Natural Acne
Salicylic Acid
Derma Wise Skin Care Ltd.
Human Otc Drug
NDC 43347-189Thera Wise Natural Acne also known as Salicylic Acid is a human otc drug labeled by 'Derma Wise Skin Care Ltd.'. National Drug Code (NDC) number for Thera Wise Natural Acne is 43347-189. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Thera Wise Natural Acne drug includes Salicylic Acid - .14 g/28g . The currest status of Thera Wise Natural Acne drug is Active.
Drug Information:
| Drug NDC: | 43347-189 |
| 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: | Thera Wise Natural Acne |
| 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: | Derma Wise Skin Care Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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 - .14 g/28g
|
| 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: | 15 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| 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: | Derma Wise Skin Care Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1804844
|
| 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 |
|---|
| 43347-189-01 | 1 TUBE in 1 BOX (43347-189-01) / 28 g in 1 TUBE | 15 Aug, 2016 | 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 astringent/anti-inflammatory
Product Elements:
Thera wise natural acne salicylic acid salicylic acid salicylic acid aloe vera leaf .alpha.-glucan oligosaccharide alpha lipoic acid alcohol squalane peppermint oil rosa moschata oil betasizofiran sodium anisate sodium levulinate sorbitan olivate tamanu oil starch, tapioca tea tree oil tocopherol water hamamelis virginiana top nori
Indications and Usage:
Use helps treat acne pimples and allows skin to heal
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 medication at a time. 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 or peeling occurs, reduce application to once a day or every other day. keep out of reach of children
When Using:
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 medication at a time. 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 or peeling occurs, reduce application to once a day or every other day.
Dosage and Administration:
Directions see warnings under " when using this product ". cleanse skin thoroughly before applying the product. apply product to affected areas one to three times daily or as directed by a health care practitioner.
Package Label Principal Display Panel:
Principal display panel - 28 g tube box thÃra wise ® natural acne treatment salicylic acid, 0.5 % clears acne blemishes without over drying prevents new acne from forming with tamanu oil, oat prebiotics, aloe vera leaf extract, rosehip seed oil, willow & witch hazel bark extracts net wt 1oz (28g) principal display panel - 28 g tube box
Further Questions:
Questions or comments? call weekdays 9am to 5pm pst @ 1.888.488.1808