Selan Antifungal Cream
FDA Label NDC 0159-2500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trividia Manufacturing Solutions, Inc for the product Selan Antifungal (NDC 0159-2500). 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, other information, inactive ingredients:, image of 4oz tube, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

 - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

 - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

Warnings

For external use only

Directions

 - Clean affected area and dry thoroughly

 - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

 - Supervise children in the use of this product

For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Other Information

store at room temperature

Inactive Ingredients:

Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide

* Please review the disclaimer below.