Select Brands Anitifungal Miconazole Nitrate Powder Spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by SELECT BRANDS DISTRIBUTORS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICONAZOLE NITRATE- miconazole nitrate antifungal powder spray aerosol, spray 
SELECT BRANDS DISTRIBUTORS

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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Select Brands Anitifungal 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

Select Brand

Miconazole Nitrate 2%

Antifungal Powder Spray

Cures mose athlete's foot

Medicated

Powder Spray

Relieves itching, burning and cracking

NET WT 4.6 OZ (130g)

Select Brand_Antifungal Miconazole Nitrate Powder Spray_APMSLSB-1.jpg

MICONAZOLE NITRATE 
miconazole nitrate antifungal powder spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15127-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ISOBUTANE (UNII: BXR49TP611)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15127-091-46130 g in 1 CAN; Type 0: Not a Combination Product12/26/201712/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/26/201712/31/2019
Labeler - SELECT BRANDS DISTRIBUTORS (012578514)

Revised: 12/2019
Document Id: 98d4a9fb-d970-e43c-e053-2995a90acefe
Set id: 5aaed568-199f-42e7-bb02-dca827e2bedc
Version: 2
Effective Time: 20191203