Label: ATHLETES FOOT SPRAY- miconazole nitrate spray 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/09

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  • Active ingredient

    Miconazole nitrate 2%

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  • Purpose

    Antifungal

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  • Uses

    • proven clinically effective in the treatment of most
    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
    • jock itch (tinea cruris)
    • effectively relieves
    • itching
    • cracking
    • burning
    • scaling
    • discomfort
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  • Warnings

    For external use only

    Flammable: Do not use near flame or spark or while smoking.

    Do not use

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

    When using this product

    • avoid contact with the eyes
    • contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F (49°C).
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • athlete’s foot or ringworm does not improve within 4 weeks
    • jock itch does not improve within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

     

    • clean the affected area and dry thoroughly
    • shake can well before use
    • hold can about 6 inches from the area to be treated
    • spray a thin layer over the 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.
    • use daily for 4 weeks for athlete’s foot and ringworm
    • use daily for 2 weeks for jock itch
    • if condition lasts longer, ask a doctor
    • this product is not effective on the scalp or nails
    • in case of clogging, clean nozzle with a pin
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  • Inactive ingredients

    alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan oleate, stearalkonium hectorite, talc

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  • Principal Display Panel

    Compare to the active ingredient in Lotrimin® AF

    New!

    Athlete's Foot Spray

    Powder Spray

    Miconazole Nitrate 2%

    Antifungal

    Cures Most Athlete’s Foot

    Relieves Itching, Burning, Scaling, and Cracking

    Athlete's Foot Spray Label

    Athlete's Foot Spray Label

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  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT SPRAY 
    miconazole nitrate spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-341
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2 g  in 100 g
    Product Characteristics
    Color WHITE (to off white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-341-90 130 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 03/02/2006
    Labeler - CVS Pharmacy (062312574)
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