Dermaclear Serum
Salicylic Acid
Allure Labs Inc
Human Otc Drug
NDC 62742-4069Dermaclear Serum also known as Salicylic Acid is a human otc drug labeled by 'Allure Labs Inc'. National Drug Code (NDC) number for Dermaclear Serum is 62742-4069. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Dermaclear Serum drug includes Salicylic Acid - 20 mg/mL . The currest status of Dermaclear Serum drug is Active.
Drug Information:
| Drug NDC: | 62742-4069 |
| 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: | Dermaclear Serum |
| 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: | Allure Labs Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 20 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: | 30 May, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | 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: | Allure Labs Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 317152
|
| 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. |
| UPC: | 0850012597209
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 62742-4069-2 | 1 TUBE in 1 CARTON (62742-4069-2) / 29.6 mL in 1 TUBE (62742-4069-1) | 30 May, 2014 | 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:
Dermaclear serum salicylic acid lactic acid, unspecified form niacinamide dimethicone yeast proline water alcohol medium-chain triglycerides glycerin butylene glycol sorbitol cetyl alcohol hyaluronate sodium ceteth-10 phosphate propylene glycol glutamine leucine serine hedera helix leaf sambucus nigra flower imperata cylindrica root malva sylvestris flowering top mentha piperita leaf alchemilla xanthochlora flowering top arnica montana flower parietaria officinalis leaf phenoxyethanol ethylhexylglycerin lavender oil carbomer copolymer type a primula veris achillea millefolium cetostearyl alcohol sorbitan olivate mangifera indica seed butter hexylresorcinol comfrey root hexylene glycol veronica officinalis flowering top melissa officinalis leaf gag salix alba bark oleanolic acid cetearyl olivate ppg-12/smdi copolymer dihexadecyl phosphate stearic acid glyceryl monostearate salicylic acid salicylic acid arctostaphylos uva-ursi leaf peg-60 almond glycerides nordihydroguaiaretic acid, (+/-)- peg-100 stearate mitracarpus hirtus whole hydrolyzed wheat protein (enzymatic, 3000 mw) maltodextrin syringa vulgaris whole xanthan gum magnesium aluminum silicate ammonia edetate disodium glycolic acid azelaic acid hexyl laurate alpha-tocopherol acetate shea butter ethyl linoleate plantago ovata seed cucumber caprylyl glycol linalool, (+/-)-
Indications and Usage:
Uses: for the treatment of acne
Warnings:
Warnings: for external use only.
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.
Dosage and Administration:
Directions clean the skin thoroughly before before applying this product. cover the entire affected area with a thin layer one to three times daily. because excessive drying of the skin may occur, stsart with one application daily, then gradually increase to two or three times daily if needed or as directed vy doctor. if bothersome dryness or peeling occurs, reduce applicaiton to ince a day or every other day. sensitivity test for a new users. apply product sparingly to one or two small affected areas during first 3 days. if no discomfort occurs, follwo the directions atated above.
Stop Use:
If irritation occurs, only use one topical acne medication at a time.
Package Label Principal Display Panel:
Manufactured for dermaquest inc hayward, ca 94544 1272 gk, nl made in usa dermaquestinc.com imgdermserum