Breakout Clearing Foaming Wash
Salicylic Acid
Dermalogica
Human Otc Drug
NDC 68479-101Breakout Clearing Foaming Wash also known as Salicylic Acid is a human otc drug labeled by 'Dermalogica'. National Drug Code (NDC) number for Breakout Clearing Foaming Wash is 68479-101. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Breakout Clearing Foaming Wash drug includes Salicylic Acid - 5 mg/mL . The currest status of Breakout Clearing Foaming Wash drug is Active.
Drug Information:
| Drug NDC: | 68479-101 |
| 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: | Breakout Clearing Foaming 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: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermalogica |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 5 mg/mL
|
| 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: | 13 May, 2013 |
| 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: | Dermalogica
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 68479-101-00 | 2 mL in 1 POUCH (68479-101-00) | 13 May, 2013 | N/A | No |
| 68479-101-01 | 50 mL in 1 BOTTLE (68479-101-01) | 13 May, 2013 | N/A | No |
| 68479-101-02 | 1 BOTTLE in 1 CARTON (68479-101-02) / 177 mL in 1 BOTTLE | 13 May, 2013 | N/A | No |
| 68479-101-03 | 295 mL in 1 BOTTLE (68479-101-03) | 13 May, 2013 | 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:
Breakout clearing foaming wash salicylic acid salicylic acid salicylic acid water cocamidopropyl betaine sodium lauroyl methyl isethionate polysorbate 20 tea tree oil orange oil, cold pressed lavender oil oleanolic acid butylene glycol annickia chlorantha bark disodium cocoamphodiacetate filipendula ulmaria root green tea leaf porphyra umbilicalis glycyrrhiza glabra sodium hydroxide ethylhexylglycerin phenoxyethanol
Indications and Usage:
Use for the treatment of acne
Warnings:
Warnings for external use only do not use around eye area. if contact occurs, flush thoroughly with water. when using this product skin irritation and dryness are 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. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use around eye area. if contact occurs, flush thoroughly with water. when using this product skin irritation and dryness are 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. 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 are 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.
Dosage and Administration:
Directions morning and night, work a pea-sized amount into a lather in wet hands. apply to dampened face and neck, massaging in circular motions while concentrating on areas of congestion and oiliness. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two daily. if bothersome dryness or peeling occurs, reduce application to once a day or every other day. avoid eye area. rinse thoroughly with warm water.
Package Label Principal Display Panel:
Principal display panel - 295 ml bottle label breakout clearing foaming wash dermalogica clear start deep cleans + purifies 10 us fl oz / 295 ml â® principal display panel - 295 ml bottle label
Further Questions:
Questions or comments call toll free 1-800-831-5150 in the us