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Product NDC Code | 24909-026 | ||||
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Drug Name | Terrasilmed antifungal |
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Type | Brand | ||||
Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 418475 | ||||
Application Number | part333C | ||||
Labeler Name | Aidance Skincare & Topical Solutions, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Clotrimazole 1.0% Antifungal
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 Wash and dry affected skin. Apply a thin layer of product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May stain fabrics.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid
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 most fungal skin infections, including ringworm, athletes foot, jock itch and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
Spl product data elements
Usually a list of ingredients in a drug product.TerrasilMed ANTIFUNGAL Clotrimazole YELLOW WAX COCONUT OIL PETROLATUM SILVER STEARATE SORBIC ACID CLOTRIMAZOLE CLOTRIMAZOLE
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.Product 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.Questions? 401-432-7750 or www.aidance.com
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 use on children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. Keep out of reach of children . If swallowed, consult a physician.
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