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Miconazole nitrate by Premier Brands of America Inc.

Medically reviewed on October 30, 2017

Dosage form: aerosol, powder
Ingredients: MICONAZOLE NITRATE 2.6g in 130g
Labeler: Premier Brands of America Inc.
NDC Code: 56104-302

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.

Antifungal Miconazole 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

​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) 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

Premier

Antifungal
Powder Spray

Miconazole 2%

For athlete's foot

  • Cures & prevents most athlete's Foot
  • Relieves itching & burning

NET WT 4.6 FL OZ (130g)

MICONAZOLE NITRATE 
antifungal miconazole powder spray aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2.6 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ISOBUTANE 
STEARALKONIUM HECTORITE 
TALC 
Packaging
#Item CodePackage Description
1NDC:56104-302-46130 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2013
Labeler - Premier Brands of America Inc. (063849780)
Establishment
NameAddressID/FEIOperations
Premier Brands of America Inc.063849780relabel(56104-302), repack(56104-302)

 
Premier Brands of America Inc.

← See all Miconazole nitrate brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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