Atrix System 1

Manufacturer
PureTek Corporation
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:34

Label at a glance#

ProductAtrix System 1
Active ingredientSALICYLIC ACID
Label structure17 sections

Indications and 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

Dosage and administration

■ 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 d...

Storage and handling

■ protect from freezing ■ avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ if skin irritation occurs or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

SPL UNCLASSIFIED SECTION

■ protect from freezing

■ avoid excessive heat

Store 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

INACTIVE INGREDIENT SECTION

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 SECTION

Call toll-free:

1-877-921-7873

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

■ if skin irritation occurs or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ Cleanse twice a day.

■ Wet face. Apply to hands, add water and work into a lather.

■ Massage face gently.
■ Rinse thoroughly and pat dry 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

STORAGE AND HANDLING SECTION

■ protect from freezing

■ avoid excessive heat

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Purified Water), Cetyl Hydroxyethylcellulose, Citrus Paradisi (Grapefruit) Peel Oil, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Glycerin, Lauryl Glucoside, Menthol, Menthyl Lactate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Lauryl Glucose Carboxylate.

Questions?

OTC - QUESTIONS SECTION

Call toll-free:

1-877-921-7873

Atrix™ System

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN4
317152salicylic acid 2 % Topical CreamPSN4
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD4
317152salicylic acid 20 MG/ML Topical CreamSCD4
562600salicylic acid 2 % Facial Cleanser TonerSY4
562600salicylic acid 2 % Facial ScrubSY4
562600salicylic acid 2 % Medicated Liquid SoapSY4
317152salicylic acid 2 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-445-08Atrix System 1118 mL in 1 BOTTLELIQUID118 mL20 mg in 1mL4
59088-446-05Atrix System 159 mL in 1 TUBECREAM59 mL20 mg in 1mL4
59088-713-00Atrix System 11 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-445ATRIX SYSTEM 1 (SALICYLIC ACID) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC20241215_c8d50ce6-5580-d3ef-e053-2a95a90a01d2.zip
59088-446ATRIX SYSTEM 1 (SALICYLIC ACID) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC20241215_c8d50ce6-5580-d3ef-e053-2a95a90a01d2.zip
59088-713ATRIX SYSTEM 1 (SALICYLIC ACID) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC, 3 package rows20241215_c8d50ce6-5580-d3ef-e053-2a95a90a01d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-713-00ML - Milliliter59088-7132842918a-0d5a-44de-b4e2-da194c13271d12022-01-06
59088-446-05ML - Milliliter59088-44661f062fe-daf5-4506-ada9-028bf31ee1da12021-11-09
59088-445-08ML - Milliliter59088-4457f82690b-b401-429e-9c34-7e38b269391112021-09-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-71359088-713-00
59088-44659088-446-05
59088-44559088-445-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atrix System 1SALICYLIC ACIDPureTek Corporationc8d50ce6-5580-d3ef-e053-2a95a90a01d22024-12-13WarningsExact identifier
ndc (package): 59088-446-05
ndc (package): 59088-445-08
ndc (package): 59088-713-00
ndc (product): 59088-713
ndc11 (package): 59088071300
ndc11 (package): 59088044508
ndc11 (package): 59088044605
spl id: 292fef30-619f-a076-e063-6394a90ac4b0
spl set id: c8d50ce6-5580-d3ef-e053-2a95a90a01d2
Atrix Acne TreatmentSALICYLIC ACIDPureTek Corporationba106b20-32aa-df90-e053-2995a90adaef2024-10-01WarningsExact identifier
ndc (package): 59088-446-05
ndc (product): 59088-446
ndc11 (package): 59088044605
Atrix Antibacterial WashSALICYLIC ACIDPURETEK CORPORATIONbd5b6f29-5b97-0853-e053-2a95a90aed592024-10-01WarningsExact identifier
ndc (package): 59088-445-08
ndc (product): 59088-445
ndc11 (package): 59088044508

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.