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| Product NDC Code | 82160-795 | ||||
|---|---|---|---|---|---|
| Drug Name | Derma pella acne care |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 2568117 | ||||
| Application Number | M006 | ||||
| Labeler Name | Pella Pharmaceuticals Co. Ltd | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Side Effects Skin irritations, dryness, redness more likely to occur when using another topical acne product at the same time, if irritation occurs, use only one product at a time.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contraindications Hypersensitivity to any of the components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Properties A lightweight, water-based alcohol-free gel. This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that clears out clogged pores, reduces blemishes, and helps to minimize blackheads and breakouts. It dissolves excess sebum, making it suitable for acne-prone skin. And also, it contains Tea tree oil which has soothing properties and improves the appearance of marks. In addition to Niacinamide (Vitamin B3) which works best to soothe and lighten skin, visibly minimize pores, and improve uneven skin tone, reduce dark spots and acne spots. It contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities. Paraben free, Alcohol free, Fragrance free.
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.Dosage and Administration - Cleanse skin thoroughly before applying product. - Dry your face and then apply a thin layer one to three times daily. - Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed. - 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 Aqua, Glycerin, Ethoxydiglycol, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), C 13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Allantoin, Laureth-7, Disodium EDTA, Ethylhexylglycerin.
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.Indications Helps to clear acne and reduce formation of new blackheads and whiteheads.
Purpose
Information about the drug product’s indications for use.Purpose Acne care gel
Spl product data elements
Usually a list of ingredients in a drug product.Derma Pella Acne Care Salicylic Acid WATER GLYCERIN LAURETH-7 ETHYLHEXYLGLYCERIN EDETATE DISODIUM ANHYDROUS TEA TREE OIL NIACINAMIDE SODIUM HYDROXIDE DIETHYLENE GLYCOL MONOETHYL ETHER ALLANTOIN PHENOXYETHANOL SALICYLIC ACID SALICYLIC ACID AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER C13-14 ISOPARAFFIN
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.Primary Package Primary Package
Secondary Package Secondary Package
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.Precautions Keep out of reach of children
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Form and Presentation Gel: Plastic Tube, 25 g
Storage and handling
Information about safe storage and handling of the drug product.Storage Conditions Store below 30 ◦ C.
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. - Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist. - Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.
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