NDC 45634-102 Acne Relief Calming Treatment And Hydrator

Salicylic Acid Acne Treatment

NDC Product Code 45634-102

NDC Code: 45634-102

Proprietary Name: Acne Relief Calming Treatment And Hydrator What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid Acne Treatment What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 45634 - Nv Perricone Llc
    • 45634-102 - Acne Relief Calming Treatment And Hydrator

NDC 45634-102-01

Package Description: 1 BOTTLE, DROPPER in 1 PACKAGE > 59 mL in 1 BOTTLE, DROPPER

NDC Product Information

Acne Relief Calming Treatment And Hydrator with NDC 45634-102 is a a human over the counter drug product labeled by Nv Perricone Llc. The generic name of Acne Relief Calming Treatment And Hydrator is salicylic acid acne treatment. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Nv Perricone Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Acne Relief Calming Treatment And Hydrator Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID .295 g/59mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CITRULLINE (UNII: 29VT07BGDA)
  • SQUALANE (UNII: GW89575KF9)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • SUCCINIC ACID (UNII: AB6MNQ6J6L)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nv Perricone Llc
Labeler Code: 45634
FDA Application Number: part333D What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acne Relief Calming Treatment And Hydrator Product Label Images

Acne Relief Calming Treatment And Hydrator Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Active Ingredient

Active IngredientSalicylic Acid 0.5%

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

Use■ For the treatment of acne.

Warnings

Warnings■ For external use only.■ 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.

Dosage & Administration

Directions■ Shake well. Apply a thin, even layer to skin in the morning.   For best results, use after cleansing with ACNE RELIEF   Gentle & Soothing Cleanser.■ Clean the skin thoroughly 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, 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.■ 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.

Inactive Ingredient

Inactive Ingredients Water/Aqua/Eau, SD Alcohol 40-B,Glycerin, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysor-bate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Poly-acrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer,C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzo-atr, Potassium Sorbate

Otc - Questions

Questions 1-888-823-7837

Product Package

ACNE RELIEFCalming Treatment& HydratorNourishes, hydrates & visiblyreduces rednessSTEP 2DAYPerricone MDACNE RELIEF90 DAY SUPPLYLactic & Succinic Acids,Citrulline, Squalane℮ 59 mL / 2 fl ozKEY INGREDIENTSLactic & Succinic Acids: AttackAcne-Causing Bacteria Theseshort-chain fatty acids help quicklyshrink blemishes by workingalongside salicylic acid to attackacne-causing bacteria for a healthierskin microbiome. They alsoprovide gentle yet effective ex-foliation for smoother, more even=looking skin.Citrulline: Fight Irritation &Visibly Reduce Redness Firstdiscovered in watermelon, thisalpha-amino acid visibly calmsskin for a clearer, more even-looking complexion. Nourishing& soothing, it is an ideal way tocounteract the irritating effectsof anti-acne ingredients.Squalane: Hydrate & NourishFound naturally in the humanbody & derived from olive oil,squalane hydrates without makingskin look or feel greasy. This lightweighthydration is ideal for oil& acne-prone skin as it helpsmaintain optimal hydration withoutclogging pores or causingblemishes.Perricone MD ACNE RELIEFPrebiotic Acne Therapy is asimple, comprehensive systemthat works with your surfaceskin’s natural microbiome tosafely, gently & effectively treat& prevent the most troublesomeacne, while restoring &maintaining a healthy skinbalance, for clearer, blemish-free skin. This powerful 2-stepregimen is clinically proven tobe non-irritating & will notstrip or over-dry skin.The Calming Treatment &Hydrator is Step 2 in your day ormorning regimen, after cleans-ing, The lightweight lotionglides onto skin to gently killacne-causing bacteria, whilenourishing with essential hy-dration.  Lactic & succinic acidssupport a healthy surface skinmicrobiome for a clearer, moreradiant 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 anddomestic components. 6511961 888 823 7837perriconemd.comExpiration &Lot Code areaOuter BoxBottlerege

* Please review the disclaimer below.

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