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Product NDC Code | 84019-009 | ||||
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Drug Name | Ureacream |
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Type | Brand | ||||
Active Ingredients |
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Route | CUTANEOUS | ||||
Dosage Form | CREAM | ||||
Application Number | M016 | ||||
Labeler Name | Shengnan (Guangzhou) Cosmetics Co., LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Urea 40%
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.Apply 1-2 times a day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water Beeswax Glycerin Salicylic Acid Butyrospermum Parkii (Shea) Butter Dimethicone Caprylic/Capric Triglyceride Cetearyl Alcohol Propylene Glycol Fragrance Phenoxyethanol Palmitic Acid Stearic Acid Tocopherol Panthenol
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.Gently clean the slin let it dry.Apply cream to theafected area. Gendy massage until fullyabsorbed
Purpose
Information about the drug product’s indications for use.PURPOSE Improves the texture of foot akin, reduicing roughness and making it smoother and more refined.
Spl product data elements
Usually a list of ingredients in a drug product.UreaCream Urea CAPRYLIC/CAPRIC TRIGLYCERIDE FRAGRANCE 13576 TOCOPHEROL SALICYLIC ACID BEESWAX BUTYROSPERMUM PARKII (SHEA) BUTTER WATER DIMETHICONE GLYCERIN PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) STEARIC ACID 1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA 1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA CETEARYL ALCOHOL PALMITIC ACID PHENOXYETHANOL PANTHENOL
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.1
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.USE SECTION Stop use and ask doctor if rash occurs.
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 SECTION Do not apply to wounds or damaged skin
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 externnl use only.Avoid direct contact with eyes
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