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| Product NDC Code | 59088-446 | ||||
|---|---|---|---|---|---|
| Drug Name | Atrix acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 317152 | ||||
| Application Number | M006 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 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.
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
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
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 Acne Treatment Salicylic Acid HEXYLENE GLYCOL OLIGOPEPTIDE-10 PHENOXYETHANOL SALICYLIC ACID SALICYLIC ACID BUTYLENE GLYCOL GLUCOSAMINE HYDROCHLORIDE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIMETHICONE GLYCERIN GLYCERYL STEARATE SE LAMINARIA DIGITATA DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) .ALPHA.-TOCOPHEROL ACETATE, DL- CETEARYL OLIVATE DECYL GLUCOSIDE SACCHAROMYCES CEREVISIAE SODIUM HYDROXIDE SORBITAN OLIVATE PALMITIC ACID WATER UREA CYCLOMETHICONE 5 ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER CAPRYLYL GLYCOL STEARIC ACID .ALPHA.-GLUCAN OLIGOSACCHARIDE SODIUM ASCORBYL PHOSPHATE GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM ETHYLHEXYLGLYCERIN
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 Acne Cream Packaged for : PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 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
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.
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.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.
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.
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