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Product NDC Code | 54473-401 | ||||
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Drug Name | Sei bella clarity clear refining foaming cleanser acne treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1038982 | ||||
Application Number | M006 | ||||
Labeler Name | Melaleuca, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 wet face pump dispenser 2-3 times onto palms of hands massage onto the face avoiding the eye area use morning and night if excessive drying of the skin occurs, start with one application daily and then gradually increase if needed if bothersome peeling or dryness occurs, reduce application to once a day or every other day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aqua (Water/Eau), Sodium Cocoyl Glutamate, Glycerin, Lauroyl/Myristoyl Methyl Glucamide, Pyrus Malus Fruit Extract, Coco-Betaine, Niacinamide, Panthenol, Salicylic Acid, Sodium Polyacrylate, Benzyl Alcohol, Capryloyl/Caproyl Methyl Glucamide, Coco-Glucoside, Glyceryl Oleate, Citric Acid, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Chlorella Vulgaris, Extract, Tocopherol
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 treats acne clears acne blemishes helps control development of new blemishes
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.Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatment Salicylic Acid WATER TOCOPHEROL BENZYL ALCOHOL SALICYLIC ACID SALICYLIC ACID PANTHENOL GLYCERYL OLEATE CITRIC ACID MONOHYDRATE GLYCERIN SODIUM POLYACRYLATE (2500000 MW) APPLE PEEL COCO-BETAINE COCO GLUCOSIDE ETHYLHEXYLGLYCERIN TRISODIUM ETHYLENEDIAMINE DISUCCINATE LAUROYL/MYRISTOYL METHYL GLUCAMIDE SODIUM COCOYL GLUTAMATE CAPRYLOYL/CAPROYL METHYL GLUCAMIDE CHLORELLA VULGARIS NIACINAMIDE
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.Sei Bella Clarity Clear Refining Foaming Cleanser (IFP) drug facts jpg.jpg Sei Bella Clarity Clear Refining Foaming Cleanser (IFP) label jpg.jpg
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 product is swallowed, get medical help or contact a Poison Control Center right away.
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 excessive irritation of the skin develops.
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 this occurs, only one medication should be used unless otherwise directed by a doctor.
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 Do not get into eyes. If contact occurs, rinse eyes 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