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Derma pella acne wash for oily skin - Medication Information

Product NDC Code 82160-764
Drug Name

Derma pella acne wash for oily skin

Type Brand
Active Ingredients
Salicylic acid 5 mg/ml
Route TOPICAL
Dosage Form SOLUTION
RxCUI drug identifier 865105
Application Number M006
Labeler Name Pella Pharmaceuticals Co. Ltd
Packages
Package NDC Code Description
82160-764-01 150 ml in 1 bottle, plastic (82160-764-01)
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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 It is well tolerated product but mild irritation, dryness, redness may occur.

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, translucent, water-based Alcohol and Sulfate free facial foaming cleanser. This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that helps remove dead skin cells, reduce blackheads and the appearance of pores, so it prevents acne. And also it contains Bacillus Ferment which is a multifunctional biotechnological ingredient obtains from microorganism isolated from natural clay, offers a cleaner smother and more beautiful skin by: - P. acne biofilm inhibition. - Reduced inflammatory response to P. acne. - Skin regenerating effect. - Cleansing activity. - Antioxidant response determined by reactive oxygen species (ROS). Also it contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities. Paraben free, Alcohol free, SLS free, SLES 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 - Use it twice a day, morning and night. - Pump 2 - 3 times onto the tips of your fingers. - Massage gently over wet skin in a circular motion for 1 min, avoiding eye area. - Rinse thoroughly, pat skin dry. - Follow with non comedogenic moisturizer. - If excessive dryness or peeling occurs, reduce usage.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Parfum, Citric Acid, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Bacillus Ferment

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 Non-irritating foaming cleanser formulated for acne-prone skins, helps gently exfoliate skin without over drying, deep cleans pores control excess oil, unclog pores and prevent new acne from forming.

Purpose

Information about the drug product’s indications for use.
Purpose Facial Cleanser for Oily Skin

Spl product data elements

Usually a list of ingredients in a drug product.
Derma Pella Acne Wash for Oily Skin Salicylic Acid BUTYLENE GLYCOL POTASSIUM SORBATE EDETATE DISODIUM ANHYDROUS BRONOPOL SODIUM C14-16 OLEFIN SULFONATE SALICYLIC ACID SALICYLIC ACID WATER POLYSORBATE 20 ALLANTOIN EDETATE SODIUM GLYCERIN COCAMIDOPROPYL BETAINE CITRIC ACID MONOHYDRATE SODIUM BENZOATE

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

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.
Forms and Presentation Solution: Plastic Bottle, 150 ml

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