GOOD NEIGHBOR PHARMACY ATHLETES FOOT RELIEF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [FORMULATED SOLUTIONS, LLC]

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GOOD NEIGHBOR PHARMACY ATHLETES FOOT RELIEF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [FORMULATED SOLUTIONS, LLC]
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NDC 23667-804-01
Set ID 46c5fa20-1285-272e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Formulated Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • 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)
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