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| Product NDC Code | 50718-0032 | ||||
|---|---|---|---|---|---|
| Drug Name | Clear acne spot treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M006 | ||||
| Labeler Name | Kamedis | ||||
| 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 2.0%
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 cleanse the skin thoroughly before applying medication cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 for children under 10 years of age and under, consult your physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, amur cork tree ( Phellodendron amurense ) bark extract, baikal skullcap ( Scutellaria baicalensis ) root extract, benzyl alcohol, capryloyl glycine, Chinese rhubarb ( Rheum palmatum ) root extract, chlorphenesin, chrysanthemum ( Chrysanthemum indicum ) flower extract, cinnamon ( Cinnamomum zeylanicum ) bark extract, common purslane ( Portulaca oleracea ) extract, fragrance, glycerin, great burnet ( Sanguisorba officinalis ) root extract, hexylene glycol, Norway spruce ( Picea abis ) extract, propanediol, sarcosine, SD Alcohol 40-C, sodium phytate, tromethamine, water, xanthan gum
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 Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Clear Acne Spot Treatment Acne Spot Treatment SALICYLIC ACID SALICYLIC ACID (C10-C30)ALKYL METHACRYLATE ESTER ALCOHOL PHELLODENDRON AMURENSE BARK SCUTELLARIA BAICALENSIS ROOT BENZYL ALCOHOL CAPRYLOYL GLYCINE CHLORPHENESIN CHRYSANTHEMUM INDICUM FLOWER PURSLANE GLYCERIN RHEUM PALMATUM ROOT SANGUISORBA OFFICINALIS ROOT HEXYLENE GLYCOL PICEA ABIES WOOD PROPANEDIOL SARCOSINE HEXASODIUM PHYTATE TROMETHAMINE WATER XANTHAN GUM CINNAMON BARK OIL
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.Carton label image description
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 Active Ingredient Salicylic Acid 2.0% Purpose Acne Treatment Use For the treatment of acne Warnings For external use only When using this product avoid unnecessary sun exposure and use sunscreen avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor Stop use and ask a doctor if irritation persists Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. Directions cleanse the skin thoroughly before applying medication cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 for children under 10 years of age and under, consult your physician Inactive Ingredients acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, amur cork tree ( Phellodendron amurense ) bark extract, baikal skullcap ( Scutellaria baicalensis ) root extract, benzyl alcohol, capryloyl glycine, Chinese rhubarb ( Rheum palmatum ) root extract, chlorphenesin, chrysanthemum ( Chrysanthemum indicum ) flower extract, cinnamon ( Cinnamomum zeylanicum ) bark extract, common purslane ( Portulaca oleracea ) extract, fragrance, glycerin, great burnet ( Sanguisorba officinalis ) root extract, hexylene glycol, Norway spruce ( Picea abis ) extract, propanediol, sarcosine, SD Alcohol 40-C, sodium phytate, tromethamine, water, xanthan gum Questions or Comments? 1-855-626-6606
Made in USA (US and non-US ingredients) Manufactured for Kamedis Paterson, NJ 07503 1-855-626-6606 www.kamedisUSA.com
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-855-626-6606
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 irritation persists
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 avoid unnecessary sun exposure and use sunscreen avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time 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
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