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| Product NDC Code | 51417-0005 | ||||
|---|---|---|---|---|---|
| Drug Name | Clearcalm non-drying acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 252296 | ||||
| Application Number | M006 | ||||
| Labeler Name | Ren Ltd. | ||||
| 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 0.5% Purpose AcneTreatment
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 the skin thoroughly before applying this product. 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 Water (Aqua), Alcohol Denat.,Glycerin, Xanthan Gum, Maritime Pine Bark Extract, Caprylyl/Capryl Glucoside, Willow Bark Extract, Xylitylglucoside, Anhydroxylitol, Sodium Benzoate, Xylitol, Propanediol, Sandalwood Wood Oil, Potassium Sorbate, Sodium Cocoyl Glutamate, Glucose, Citric Acid, Glyceryl Caprylate, Polyglyceryl-6 Oleate, Thyme Leaf Oil, Chlorella Extract, Sodium Surfactin, Lactic Acid, Sodium Lactate, Farnesol
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 of acne
Purpose
Information about the drug product’s indications for use.Purpose AcneTreatment
Spl product data elements
Usually a list of ingredients in a drug product.Clearcalm Non-Drying Acne Treatment SALICYLIC ACID WATER ALCOHOL GLYCERIN XANTHAN GUM CAPRYLYL/CAPRYL OLIGOGLUCOSIDE WILLOW BARK XYLITYLGLUCOSIDE ANHYDROXYLITOL SODIUM BENZOATE XYLITOL PROPANEDIOL POTASSIUM SORBATE SODIUM COCOYL GLUTAMATE ANHYDROUS DEXTROSE CITRIC ACID MONOHYDRATE GLYCERYL MONOCAPRYLATE LACTIC ACID, UNSPECIFIED FORM SODIUM LACTATE FARNESOL 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.Package Labeling: Label
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.Drug Facts
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. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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