TopCare Miconazole Nitrate Powder Spray

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]

MICONAZOLE NITRATE- miconazole nitrate antifungal powder spray aerosol, spray 
Topco Associates LLC

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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TopCare Miconazole Nitrate Powder Spray

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

• avoid contact with the 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

​Do not use

on children under 2 years of age unless directed by a doctor.

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (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 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

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

​Questions?

call 1-866-964-0939

​Principal Display Panel

TopCare

Medicated

Antifungal Powder Spray

Miconazole Nitrate 2%

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

NET WT 4.6 OZ (130 g)

MICONAZOLE NITRATE 
miconazole nitrate antifungal powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-026
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
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-026-46	130 g in 1 CAN; Type 0: Not a Combination Product	01/03/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/03/2012	12/31/2019

Labeler - Topco Associates LLC (006935977)

Revised: 12/2019

Document Id: 995e2836-c9d9-7710-e053-2a95a90adc76

34390-5

Set id: 1d696b23-f1d4-434a-b6e5-b1710d3fef1d

Version: 5

Effective Time: 20191210