MICONAZOLE NITRATE- athletes foot powder spray talc free aerosol, powder

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
• relieves symptoms of athlete's foot, including itching burning and cracking

WARNINGS

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

When using this product

• do not get into eyes or mouth
• use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• for athlete's foot: 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 for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
• this product is not effective on the scalp or nails
• in case clogging, clear nozzle under running water

Other information

store between 20º and 30ºC (68ºF and 86º)

Inactive ingredients

SD alcohol 40-B(10%w/w), isobutane (propellant), stearalkonium hectorite, talc

Questions?

call 1-866-964-0939

Principal Display Panel

Topcare

MEDICATED

AntifungalPowder Spray

Miconazole Nitrate 2%

• Cures most athlete's foot
• Relieves itching, cracking & burning
• Talc-free

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
athletes foot powder spray talc free aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-384
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2.6 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
KAOLIN (UNII: 24H4NWX5CO)
ALCOHOL (UNII: 3K9958V90M)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-384-46	130 g in 1 CAN; Type 0: Not a Combination Product	12/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/07/2017

Labeler - Topco Associates LLC (006935977)