Terrasilmed Antifungal
FDA Label NDC 24909-026

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Scientific, Inc., Dba Aidance Skincare & Topical Solutions for the product Terrasilmed Antifungal (NDC 24909-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients                purpose, uses, warnings, directions, inactive ingredients, questions?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients                Purpose

Clotrimazole 1.0%              Antifungal

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.

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.

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 Ingredients

Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid

Questions?

401-432-7750 or www.aidance.com

Product Label

Image Description (Antifungal Image)

Image Description (Antifungal Image)

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