Active Ingredient
Salicylic Acid 2%
Salicylic Acid 2%
Atrix Acne Treatment Cream
FDA Label NDC 59088-446
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Atrix Acne Treatment (NDC 59088-446). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
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
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.
■ 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
■ 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.
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.
■ 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
■ 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.
■ protect from freezing
■ avoid excessive heat
Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].
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
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.
Otc - Questions
Call toll-free:
1-877-921-7873
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
Questions?
Call toll-free:
1-877-921-7873
* Please review the disclaimer below.
