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Atrix system 1 - Medication Information

Product NDC Code 59088-713
Drug Name

Atrix system 1

Type Brand
Dosage Form KIT
RxCUI drug identifier 317152,
562600
Labeler Name PureTek Corporation
Packages
Package NDC Code Description
59088-713-00 1 kit in 1 kit (59088-713-00) * 59 ml in 1 tube (59088-446-05) * 118 ml in 1 bottle (59088-445-08)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic Acid 2% Active ingredient Salicylic Acid 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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. Directions ■ 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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 Inactive ingredients 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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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 Use ■ 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

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment Purpose Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Atrix System 1 Salicylic Acid Atrix Acne Treatment Salicylic Acid CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER GLUCOSAMINE HYDROCHLORIDE CYCLOMETHICONE 5 CAPRYLYL GLYCOL STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- BUTYLENE GLYCOL DIMETHICONE CETEARYL OLIVATE OLIGOPEPTIDE-10 PHENOXYETHANOL DECYL GLUCOSIDE SACCHAROMYCES CEREVISIAE SODIUM ASCORBYL PHOSPHATE SALICYLIC ACID SALICYLIC ACID UREA .ALPHA.-GLUCAN OLIGOSACCHARIDE GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL SODIUM HYDROXIDE GLYCERIN GLYCERYL STEARATE SE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SORBITAN OLIVATE PALMITIC ACID LAMINARIA DIGITATA ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER Atrix Antibacterial Wash Salicylic Acid GRAPEFRUIT OIL EDETATE DISODIUM GLYCERIN MENTHYL LACTATE, (-)- APPLE ROSEMARY .ALPHA.-IONENE COCAMIDOPROPYL BETAINE EUROPEAN ELDERBERRY SALICYLIC ACID SALICYLIC ACID WATER CETYL HYDROXYETHYLCELLULOSE (350000 MW) LAURYL GLUCOSIDE MENTHOL, UNSPECIFIED FORM SODIUM LAURYL GLYCOL CARBOXYLATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Atrix™ System Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Atrix™ Acne Treatment Cream (2 fl oz ) 59 mL Drug Facts Other information ■ 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. Atrix™ Antibacterial Wash (4 fl oz ) 118 mL

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Call toll-free: 1-877-921-7873 Questions? Call toll-free: 1-877-921-7873

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor ■ if skin irritation occurs or gets worse Stop use and ask a doctor ■ if skin irritation occurs or gets worse

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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. 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ■ protect from freezing ■ avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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. 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API