DESENEX- miconazole nitrate aerosol, spray 
Novartis Consumer Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

•
cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
•
relieves itching, scaling, burning, and discomfort that can accompany these conditions

Warnings

For external use only

Flammability Warning: Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperature above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do Not Use

•
in or near the mouth or the eyes
•
for nail or scalp infections

When using this product

•
do not get into the eyes or mouth

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 of age and older
•
wash the affected area with soap and water and dry completely before applying
•
shake can well, hold 4” to 6” from skin
•
spray 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
•
for athlete’s foot 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 daily for 4 weeks
•
supervise children in the use of this product
•
children under 2 years of age: ask a doctor

Other information

•
store at controlled room temperature 20-25°C (68-77°F)
•
see bottom of can for lot number and expiration date
•
if clogging occurs, remove button and clean nozzle with a pin

Inactive ingredients

polyethylene glycol 300, polysorbate 20, SD alcohol 40-B (15%w/w)
Propellant: dimethyl ether

Questions or comments?

call 1-800-452-0051 24 hours a day, 7 days a week

Additional information listed on other panels

Distributed by:  

Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622

©20XX

Principal Display

NDC 0067-0969-46

Desenex®
2% Miconazole Nitrate, Antifungal
Cures Most Athlete’s Foot
Relieves Itching & Burning

Liquid Spray

Net Wt. 4.6 oz (133g)

Desenex Liquid Spray 4.6oz label
DESENEX 
miconazole nitrate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0969
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DIMETHYL ETHER (UNII: AM13FS69BX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-0969-46133 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/200606/24/2015
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 6/2015
Document Id: 78d89735-b5d1-4213-860d-eff07d6fcfd6
Set id: 8fc53acf-6393-44a4-adcf-18f5b506c8d2
Version: 2
Effective Time: 20150624
 
Novartis Consumer Health, Inc.