DESENEX- miconazole nitrate powder

Desenex by

Drug Labeling and Warnings

Desenex by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US). 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 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 controlled room temperature 20-25°C (68-77°F)
• 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: 0067-0949-30

Prescription Strength

Desenex®

Powder

2% Miconazole Nitrate, Antifungal

Absorbs Wetness

CURES MOST ATHLETE’S FOOT

RELIEVES ITCHING & BURNING

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

NET WT. 3 oz (85 g)

Distributed by:  

GSK Consumer Healthcare

Warren, NJ 07059

©2016 GSK or its licensor.

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INGREDIENTS AND APPEARANCE

DESENEX 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0949
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-0949-15	43 g in 1 CONTAINER; Type 0: Not a Combination Product	08/03/2009	07/31/2020
2	NDC: 0067-0949-30	85 g in 1 CONTAINER; Type 0: Not a Combination Product	08/03/2009	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/03/2009	07/31/2020

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) (079944263)