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Product NDC Code | 54473-221 | ||||
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Drug Name | Clarity clear skin essentials deep-cleaning astringent |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 199308 | ||||
Application Number | part333D | ||||
Labeler Name | Melaleuca, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 0.5%
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 this product • moisten a cotton ball, 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients allantoin, aloe barbadensis leaf juice powder, butylene glycol, camellia oleifera (green tea) leaf extract, chamomillia recuttia (matricaria) flower extract, fragrance, hamamelia virginiana (witch hazel) extract, melaleuca alternifolia (tea tree) leaf oil, menthol panthenol, pentylene glycol, polyquaternium-7 propandiol, PPG-5-ceteth-20, SD alcohol 40-B, sodium citrate, water, zinc PCA
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.Use for the treatment and management of acne
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.Clarity Clear Skin Essentials Deep-Cleaning Astringent SALICYLIC ACID BUTYLENE GLYCOL CAMELLIA OLEIFERA LEAF CHAMOMILE HAMAMELIS VIRGINIANA TOP MENTHOL PANTHENOL PENTYLENE GLYCOL PPG-5-CETETH-20 PROPANEDIOL SODIUM CITRATE WATER ZINC PIDOLATE 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.astringentbck.jpg astringentfrt.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 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 medicationat 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. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medicationat the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor. Stop use and ask a doctor if excessive irritation of the skin develops
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