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Atrix clarifying toner - Medication Information

Product NDC Code 59088-444
Drug Name

Atrix clarifying toner

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 251577
Application Number M006
Labeler Name PureTek Corporation
Packages
Package NDC Code Description
59088-444-08 118 ml in 1 bottle (59088-444-08)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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 product ■ moisten a cotton ball and 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aqua (Purified Water), Benzalkonium Chloride, Benzyl Alcohol, Citrus Paradisi (Grapefruit) Peel Oil, Ethoxydiglycol, Ethyl Alcohol, Glycerin, Menthol, Menthyl Lactate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Hydroxide.

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.
Use ■ for the treatment of acne ■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads ■ helps prevent the development of acne pimples, acne blemishes, whiteheads and blackheads

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Atrix Clarifying Toner Salicylic Acid WATER BENZALKONIUM CHLORIDE BENZYL ALCOHOL GRAPEFRUIT OIL DIETHYLENE GLYCOL MONOETHYL ETHER ALCOHOL GLYCERIN MENTHOL, UNSPECIFIED FORM MENTHYL LACTATE, (-)- APPLE ROSEMARY EUROPEAN ELDERBERRY SALICYLIC ACID SALICYLIC ACID SODIUM HYDROXIDE

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™ Clarifying Toner Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 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.
Drug Facts

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
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

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.

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. Flammable: Keep away from fire or flame. 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