DESENEX- miconazole nitrate powder
GlaxoSmithKline Consumer Healthcare Holdings (US)

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)
•: 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

12922

DESENEX
miconazole nitrate powder

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/03/2009	07/31/2020

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

Revised: 11/2018

Document Id: ff12a995-2506-400f-a3ea-1fe0bb5dcf53

Set id: c2ec4973-07d6-480f-b47a-ac57b4b703f1

Version: 3

Effective Time: 20181116

GlaxoSmithKline Consumer Healthcare Holdings (US)