Label: LOTRIMIN ANTIFUNGAL- miconazole nitrate aerosol, powder

  • 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 September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 except under the advice and supervision of 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.

    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.

  • 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 between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

  • Questions?

    1-866-360-3266

  • Distribution

    Distributed by: Bayer HealthCare LLC, Whippany NJ

  • PRINCIPAL DISPLAY PANEL - 133 g Can Label

    Powder Spray

    goes on dry

    NDC 11523-0544-2

    LOTRIMIN® AF

    ANTIFUNGAL

    miconazole nitrate

    Clinically Proven To Cure

    Most Athlete's Foot

    • Relieves Itching,

      Burning, Cracking

      & Scaling

    NET WT 133g (4.6 OZ)

    Label

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN  ANTIFUNGAL
    miconazole nitrate aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0544
    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
    ISOBUTANE (UNII: BXR49TP611)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorwhite (White to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0544-2133 g in 1 CAN; Type 0: Not a Combination Product09/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/1993
    Labeler - Bayer Healthcare LLC. (112117283)
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