Acne Relief Calming Treatment And Hydrator
Salicylic Acid Acne Treatment
Nv Perricone Llc
Human Otc Drug
NDC 45634-102Acne Relief Calming Treatment And Hydrator also known as Salicylic Acid Acne Treatment is a human otc drug labeled by 'Nv Perricone Llc'. National Drug Code (NDC) number for Acne Relief Calming Treatment And Hydrator is 45634-102. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Acne Relief Calming Treatment And Hydrator drug includes Salicylic Acid - .295 g/59mL . The currest status of Acne Relief Calming Treatment And Hydrator drug is Active.
Drug Information:
| Drug NDC: | 45634-102 |
| 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: | Acne Relief Calming Treatment And Hydrator |
| 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 Acne Treatment |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nv Perricone Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - .295 g/59mL
|
| 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: | 01 Aug, 2019 |
| 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: | NV Perricone LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199134
|
| 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 |
|---|
| 45634-102-01 | 1 BOTTLE, DROPPER in 1 PACKAGE (45634-102-01) / 59 mL in 1 BOTTLE, DROPPER | 01 Aug, 2019 | 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:
Acne relief calming treatment and hydrator salicylic acid acne treatment salicylic acid salicylic acid water alcohol glycerin c12-15 alkyl lactate povidone, unspecified dimethicone polysorbate 20 citrulline squalane lactic acid succinic acid polyacrylamide (10000 mw) dimethicone/vinyl dimethicone crosspolymer (hard particle) c13-14 isoparaffin laureth-7 phenoxyethanol sodium benzoate potassium sorbate
Indications and Usage:
Use â for the treatment of acne.
Warnings:
Warnings â for external use only. â when using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. â if irritation occurs, only use one topical acne medication at a time. â keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions â shake well. apply a thin, even layer to skin in the morning. for best results, use after cleansing with acne relief gentle & soothing cleanser. â clean the skin thoroughly before applying this product. â cover the entire affected area with a thin layer one to three times daily. â 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. â if bothersome dryness or peeling occurs, reduce application to once a day or every other day. â sensitivity test for a new user apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated above.
Package Label Principal Display Panel:
Product package acne relief calming treatment & hydrator nourishes, hydrates & visibly reduces redness step 2 day perricone md acne relief 90 day supply lactic & succinic acids, citrulline, squalane â® 59 ml / 2 fl oz key ingredients lactic & succinic acids: attack acne-causing bacteria these short-chain fatty acids help quickly shrink blemishes by working alongside salicylic acid to attack acne-causing bacteria for a healthier skin microbiome. they also provide gentle yet effective ex- foliation for smoother, more even= looking skin. citrulline: fight irritation & visibly reduce redness first discovered in watermelon, this alpha-amino acid visibly calms skin for a clearer, more even- looking complexion. nourishing & soothing, it is an ideal way to counteract the irritating effects of anti-acne ingredients. squalane: hydrate & nourish found naturally in the human body & derived from olive oil, squalane hydrates without making skin look or feel greasy. this lightweight hydration is ideal for oil & acne-prone skin as it helps maintain optimal hydration without clogging pores or causing blemishes. perricone md acne relief prebiotic acne therapy is a simple, comprehensive system that works with your surface skinâs natural microbiome to safely, gently & effectively treat & prevent the most troublesome acne, while restoring & maintaining a healthy skin balance, for clearer, blemish- free skin. this powerful 2-step regimen is clinically proven to be non-irritating & will not strip or over-dry skin. the calming treatment & hydrator is step 2 in your day or morning regimen, after cleans- ing, the lightweight lotion glides onto skin to gently kill acne-causing bacteria, while nourishing with essential hy- dration. lactic & succinic acids support a healthy surface skin microbiome for a clearer, more radiant complexion, while citrul- line & squalane fight irritation, nourish, hydrate, soothe & vis- ibly reduce redness. dist. by: nv perricone llc, san francisco, ca 94111. made in usa of foreign and domestic components. 651196 1 888 823 7837 perriconemd.com expiration & lot code area outer box bottle rege acneday 59 ml box acneday 59 ml btl
Further Questions:
Questions 1-888-823-7837