Terrasil Jock Itch Treatment Maximum Strength Ointment
FDA Label NDC 24909-214

9 label sections · Submitted to the FDA by Aidance Skincare & Topical Solutions, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Skincare & Topical Solutions, Llc for the product Terrasil Jock Itch Treatment Maximum Strength (NDC 24909-214). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of jock itch (tinea cruris). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Warnings

For external use only. Do not use onchildren 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 2 weeks, discontinue use and consult a physician. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, zinc oxide

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Questions?

401-432-7750 or www.aidance.com

Product Label

Image Description (Update Image 214)

Image Description (Update Image 214)

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