NDC 45634-100 Acne Relief Maximum Strength Spot Gel

Salicylic Acid Acne Treatment

NDC Product Code 45634-100

NDC Code: 45634-100

Proprietary Name: Acne Relief Maximum Strength Spot Gel 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
    • 45634-100 - Acne Relief Maximum Strength Spot Gel

NDC 45634-100-01

Package Description: 1 TUBE in 1 PACKAGE > 14.1 g in 1 TUBE

NDC Product Information

Acne Relief Maximum Strength Spot Gel with NDC 45634-100 is a a human over the counter drug product labeled by Nv Perricone Llc. The generic name of Acne Relief Maximum Strength Spot Gel is salicylic acid acne treatment. The product's dosage form is gel and is administered via topical form.

Labeler Name: Nv Perricone Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Maximum Strength Spot Gel 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 2 g/100g

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)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUCROSE (UNII: C151H8M554)
  • CITRULLINE (UNII: 29VT07BGDA)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • UREA (UNII: 8W8T17847W)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • SUCCINIC ACID (UNII: AB6MNQ6J6L)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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 Maximum Strength Spot Gel Product Label Images

Acne Relief Maximum Strength Spot Gel 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 2.0%

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

Use■ For the treatment of acne.

Warnings

Warnings■ For external use only. ■When Using This Product skin irritationand dryness are more likely to occur if youuse another topical acne medication atthe same time. ■ If irritation occurs, onlyuse one topical acne medication at atime. ■ Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.

Dosage & Administration

Directions ■ Clean the skin thoroughlybefore applying this product. ■ Cover theentire affected area with a thin layer oneto three times daily. ■ Because excessivedrying of the skin may occur, start with oneapplication daily, then gradually increaseto two or three times daily if needed or asdirected by a doctor. ■ If bothersome drynessor peeling occurs, reduce applicationto once a day or every other day. ■ SensitivityTest for a New User Apply productsparingly to one or two small affectedareas during the first 3 days. If no discomfortoccurs, follow the directions stated above.

Inactive Ingredient

Inactive Ingredients Water/Aqua/Eau,SD Alcohol 40-B, Propanediol, HamamelisVirginiana (Witch Hazel) Water, Glycerin,Sucrose, Citrulline, Hydroxyethylcellulose,Urea, Panthenol, Lactic Acid, MelaleucaAlternifolia (Tea Tree) Leaf Oil, Sodium Hydroxide,Tetrasodium Glutamate Diacetate,Succinic Acid, Alcohol, Polysorbate 20

Otc - Questions

Questions1-888-823-7837

Product Package

ACNE RELIEFMaximum Strength Spot GelMinimizes blemishes & helps preventfuture breakoutsPerricone MDACNE RELIEFMaximumStrengthSpot GelSalicylic AcidAcne Treatment90 DAY SUPPLYLactic & Succinic Acids,Citrulline, Tea Tree Oil℮ Net Wt 0.5oz / 14.1 gKEYINGREDIENTSLactic & SuccinicAcids: Attack Acne-Causing BacteriaThese short-chain fattyacids help quickly shrinkblemishes by workingalongside salicylic acidto attack acne-causingbacteria for a healthierskin microbiome. Theyalso provide gentle yeteffective exfoliation forsmoother, more even-lookingskin.Citrulline: Fight Irritation& Visibly ReduceRedness First discoveredin watermelon,this alpha-amino acidvisibly calms skin fora clearer, more even-lookingcomplexion.Nourishing & soothing,it is an ideal way tocounteract the irritatingeffects of antiacneingredients.Tea Tree Oil: Cleanse,Clarify & Soothe Thispowerful essential oilhelps visibly reduceredness & calm skin.It easily penetratesskin’s surface, featuresa light, refreshing scentsimilar to eucalyptus& has been used forcenturies in traditionalAustralian medicine.This maximum strength invisible gel worksovertime to reduce blemishes & preventfuture breakouts by killing acne-causingbacteria, unclogging pores & absorbingexcess oil without over-drying.Dist. By: NV Perricone LLC, San Francisco,CA 94111. Made in USA of foreign anddomestic components. 6511991 888 823 7837 perriconemd.comExpiration &Lot Code areaOuter BoxTuberege

* Please review the disclaimer below.

Previous Code
45632-736
Next Code
45634-101