FDA Label for Desenex

View Indications, Usage & Precautions

Desenex Product Label

The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Miconazole nitrate 2%


Purpose



Antifungal


Uses



  • cures most athlete’s foot (tinea pedis)
  • relieves itching, burning, cracking and discomfort associated with athlete’s foot

Warnings



For external use only


Do Not Use



  • in the eyes
  • for nail or scalp infections

When Using This Product



  • do not get into the eyes

Stop Use And Ask A Doctor If



  • irritation occurs or gets worse
  • no improvement within 4 weeks

Keep Out Of Reach Of Children.



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


Directions



  • adults and children 2 years and older
  • wash the affected area with soap and water and dry completely before applying
  • apply a thin layer over affected area twice a day (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once a day
  • use every day for 4 weeks
  • children under 2 years of age: ask a doctor

Other Information



  • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
  • See container bottom for lot number and expiration date

Inactive Ingredients



corn starch, fragrance, talc


Questions Or Comments?



call 1-800-452-0051


Principal Display



NDC 0316-0225-30

Prescription Strength

Desenex®

Powder

Miconazole Nitrate 2%, Antifungal

Absorbs Wetness

CURES MOST ATHLETE’S FOOT

RELIEVES ITCHING & BURNING

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

Net wt. 3 oz (85 g)

DESENEX is registered trademark of Crown Laboratories, Inc.

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

©2018 Crown Laboratories, Inc.

P11527.00


* Please review the disclaimer below.