Label: MICONAZOLE NITRATE- antifungal miconazole powder spray aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 29, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Miconozole nitrate 2%

  • Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
    • relieves symtoms 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 120°F. Intentional misuse by deliberately concentrationg and inhaling contents can be harmful or fatal.

    When using this product

    • avoid contact with the eyes or mouth
    • use only as directed

    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 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 condition persists, consult a doctor
    • this product is not effective on scalp or nails
    • if nozzle clogs, clean with a pin
  • Other infomation

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

  • Inactive ingredients

    disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

  • Questions

    Call 1-866-964-0939

  • PRINCIPAL DISPLAY PANEL

    Foot Powder Spray

    Miconazole Nitrate 2%/

    ANTIFUNGAL

    Cures Most Athelete's Foot

    Relieves Itching, Cracking and Burning

    Talc Free

    NET WT 4.6 OZ (130g)

    image 3

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazole powder spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-121
    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
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-121-01130 g in 1 CANISTER; Type 0: Not a Combination Product04/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/12/2022
    Labeler - Premier Brands of America Inc. (117557458)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!