Desenex Powder
FDA Label NDC 0316-0225

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Desenex (NDC 0316-0225). 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, do not use, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • Cures most athlete’s foot (tinea pedis)
  • Relieves itching, burning, cracking, and discomfort

Warnings

For external use only.

Avoid contact with eyes.

Do Not Use

on children under 2 years of age unless directed by a doctor.

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer,
consult a doctor. This product is not effective on the scalp or nails.

Other Information

  • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

Questions?

call 1-833-279-6522

Principal Display

Desenex®

Antifungal Foot Powder

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Triple Action Powder

Relieves Itching, Burning, and Scaling

Attacks and Absorbs Moisture

All Day Odor Control

NET WT. 1.5 oz [43g]

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

©2023 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc . Johnson City, TN 37604

DESENEX is a registered trademark of Crown Laboratories, Inc.

P12319.01

* Please review the disclaimer below.