DESENEX- miconazole nitrate powder

Desenex by

Drug Labeling and Warnings

Desenex by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

New & Improved

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.

P12319.00

INGREDIENTS AND APPEARANCE

DESENEX 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, TAPIOCA (UNII: 24SC3U704I)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0225-01	43 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2023
2	NDC: 0316-0225-02	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/19/2023

Labeler - Crown Laboratories (079035945)