Label: GOOD NEIGHBOR PHARMACY ATHLETES FOOT RELIEF ANTIFUNGAL- miconazole nitrate spray

  • NDC Code(s): 23667-804-01
  • Packager: Formulated Solutions, LLC
  • 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 January 23, 2017

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

  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

    Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlet's foot (Tinea pedis), Jack itch (tinea cruis) and ringworm (tinea corporis)
    • for effective relief if itching, cracking, burning, scalling and discomfort
  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    Do not use

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

    When using this product

    • avoid contact with the eyes
    • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
    • contents under pressure. Do nor punture or incinerate. Do not store at temperature above 120°F (49°C).

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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 toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if condition persist longer, ask a doctor
    • this product is not effective on the scalp or nails
    • in case of clpgging, clean nozzle with a pin
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive Ingredients

    alcohol denat, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monoleate, stearalkonium hectorite, talc

  • Questions or comments?

    1-800-719-9260

  • Package Labeling:

    Antifungal 804

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY ATHLETES FOOT RELIEF ANTIFUNGAL 
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23667-804-01130 g in 1 CAN; Type 0: Not a Combination Product01/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/20/2017
    Labeler - Formulated Solutions, LLC (143266687)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulated Solutions, LLC143266687manufacture(23667-804)