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| Product NDC Code | 68327-073 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cover fx mattifying primer plus acne treatment |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 251380 | ||||||||
| Application Number | part333D | ||||||||
| Labeler Name | Cover FX Skin Care Inc | ||||||||
| 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 1%
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 skin thoroughly before applying. Cover entire affected area with a thin layer 1 to 3 times daily. Because excessive drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Cyclopentasiloxane, Salix Nigra (Willow) Bark Extract, Water/Eau, Dimethicone Crosspolymer, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-PEG/PPG-14/14 Dimethicone, Vaccinium Myrtillus Fruit Extract, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Phenyl Methicone, Saccharum Officinarum (Sugar Cane) Extract/Extrait de canne a sucre, Bisabolol, Caprylyl Glycol, Tocopherol, Dimethiconol, Phenoxyethanol, PEG-60 Almond Glycerides, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Enantia Chlorantha Bark Extract, Citrus Limon (Lemon) Fruit Extract, Phytosphingosine, Tetrahexyldecyl Ascorbate, Ethyl Linoleate, Ethyl Linolenate, Ethyl Oleate, Carbomer, Silica, Polysorbate 20, Oleanolic Acid, Nordihydroguaiaretic Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7
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. Helps treat acne pimples and allows skin to heal.
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.Cover FX Mattifying Primer Plus Acne Treatment Salicylic Acid CYCLOMETHICONE 5 SALIX NIGRA BARK WATER BUTYLENE GLYCOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) BIS-PEG/PPG-14/14 DIMETHICONE BILBERRY GLYCERIN DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) SQUALANE PHENYL METHICONE (500 CST) SUGARCANE .ALPHA.-BISABOLOL, (+)- CAPRYLYL GLYCOL TOCOPHEROL DIMETHICONOL (40 CST) PHENOXYETHANOL PEG-60 ALMOND GLYCERIDES ACER SACCHARUM BARK/SAP ORANGE ANNICKIA CHLORANTHA BARK LEMON PHYTOSPHINGOSINE TETRAHEXYLDECYL ASCORBATE ETHYL LINOLEATE ETHYL LINOLENATE ETHYL OLEATE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) SILICON DIOXIDE POLYSORBATE 20 OLEANOLIC ACID MASOPROCOL PALMITOYL TRIPEPTIDE-1 PALMITOYL TETRAPEPTIDE-7 SALICYLIC ACID SALICYLIC ACID
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.PRODUCT PACKAGING COVER FX MATTIFYING PRIMER +ACNE TREATMENT mattifying
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.OTHER INFORMATION Report serious adverse event to 575 Fifth Ave 14th Floor New York, NY 10017
COMPANY INFORMATION Dist. By: Cover FX Skin Care Inc. Toronto Ontario Canada M3J 2W8 Made in Canada www.coverfx.com
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.
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.
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
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