NDC 59088-446 Atrix Acne Treatment

Salicylic Acid

NDC Product Code 59088-446

NDC CODE: 59088-446

Proprietary Name: Atrix Acne Treatment 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

  • 59088 - Puretek Corporation

NDC 59088-446-05

Package Description: 59 mL in 1 TUBE

NDC Product Information

Atrix Acne Treatment with NDC 59088-446 is a a human over the counter drug product labeled by Puretek Corporation. The generic name of Atrix Acne Treatment is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Puretek Corporation

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Atrix Acne Treatment 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 20 mg/mL

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)
  • UREA (UNII: 8W8T17847W)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • PALMITIC ACID (UNII: 2V16EO95H1)

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: Puretek Corporation
Labeler Code: 59088
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: 04-06-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Atrix Acne Treatment Product Label Images

Atrix Acne Treatment 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

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses:

■ for the treatment of acne

■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads

■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads

Warnings

For external use only

When Using This Product

■ skin irritation and dryness is 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.■ rinse right away with water if it gets in eyes.

Stop Use And Ask A Doctor

■ if skin irritation occurs or gets worse

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ 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.Use under the direction of a medical practitioner.

Other Information

■ protect from freezing■ avoid excessive heatStore at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Avoid excessive heat. Do not use if package is damaged.
Keep this and all medication out of reach of children.

Inactive Ingredients

Allyl Methacrylates Crosspolymer, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cyclopentasiloxane, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizinate, Disodium EDTA, Ethylhexylglycerin, Alpha-Glucan Oligosaccharide, Glucosamine HCl, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Laminaria Digitata (Algae) Extract, Oligopeptide- 10, Palmitic Acid, Phenoxyethanol, Polysilicone-11, Saccharomyces Cerevisiae Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, DL- alpha- Tocopheryl Acetate, Urea

Otc - Questions

Call toll-free:1-877-921-7873

Atrix Acne Cream

Packaged for :
PureTek Corporation
Panorama City, CA 91402

For questions or information

call toll-free:
877-921-7873

* Please review the disclaimer below.