Label: SIGNATURE CARE ATHLETES FOOT- miconazole nitrate spray

  • Category: HUMAN OTC DRUG LABEL

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 25, 2017

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    •
    proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    •
    for effective relief of itching, cracking, burning, scaling 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 not puncture 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 toes; wear well-fitting, ventilated shoes and change shoes and socks 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 persists longer, ask a doctor
    •
    this product is not effective on the scalp or nails
    •
    in case of clogging, 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 monooleate, stearalkonium hectorite, talc

  • Questions or comments?

    1-888-723-3929

  • Principal Display Panel

    Athlete’s Foot Spray

    Miconazole Nitrate 2%

    Antifungal

    POWDER SPRAY

    COMPARE TO Lotrimin® AF Antifungal Powder Spray active ingredient

    Cures most athlete’s foot

    Relieves itching, burning, cracking and scaling

    NET WT 4.6 OZ (130 g)

    Signature Care Athlete's Foot Spray
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ATHLETES FOOT 
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TALC (UNII: 7SEV7J4R1U)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    Product Characteristics
    ColorWHITE (to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-341-90130 g in 1 CAN; Type 0: Not a Combination Product10/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/09/2015
    Labeler - Safeway (009137209)
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