Perfect Purity Oil Free Acne Wash
Salicyclic Acid
Davion, Inc
Human Otc Drug
NDC 42669-009Perfect Purity Oil Free Acne Wash also known as Salicyclic Acid is a human otc drug labeled by 'Davion, Inc'. National Drug Code (NDC) number for Perfect Purity Oil Free Acne Wash is 42669-009. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Perfect Purity Oil Free Acne Wash drug includes Salicylic Acid - 2 g/100g . The currest status of Perfect Purity Oil Free Acne Wash drug is Active.
Drug Information:
| Drug NDC: | 42669-009 |
| 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: | Perfect Purity Oil Free Acne Wash |
| 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: | Salicyclic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Davion, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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: | 27 Feb, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 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: | part358H |
| 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: | Davion, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 562600
|
| 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 |
|---|
| 42669-009-06 | 177 g in 1 BOTTLE (42669-009-06) | 27 Feb, 2017 | 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 wash
Product Elements:
Perfect purity oil free acne wash salicyclic acid water sodium laureth-3 sulfate cocamidopropyl betaine peg-150 distearate propylene glycol coco monoethanolamide peg-80 sorbitan laurate dipropylene glycol sodium chloride methylisothiazolinone methylchloroisothiazolinone aloe vera leaf chamaemelum nobile flower edetate disodium anhydrous fd&c yellow no. 5 fd&c red no. 40 salicylic acid salicylic acid
Indications and Usage:
Uses for the treatment of acne
Warnings:
Warnings for external use only. ask a doctor or pharmacist before use if you are using other topical acne medication at the same time or immediately following use of this product. this may increase dryness or irritation of the skin. if this occurs, only one medication should be used, unless directed by a doctor. when using this product do not use in or near the eyes. incase of eye contact, rinse eyes thoroughly with water. 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 do not use in or near the eyes. incase of eye contact, rinse eyes thoroughly with water.
Dosage and Administration:
Directions use twice daily apply water to face and hands dispense into hands and lather apply to face, nose area and neck gently massage into skin rinse thoroughly with tepid water.
Package Label Principal Display Panel:
Principal display panel ndc 42669-009-06 compare to neutrogena oil-free acne wash perfect purity oil-free acne wash with 2% salicylic acid effective yet gentle cleanser for cleaner, clearer complexion 6 fl oz (177 ml) label
Further Questions:
Questions 1-866-379-4222 or visit www.davioninc.com