LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]

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LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]
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NDC 11523-0544-2
Set ID 3650ee3d-b285-46b9-a80b-e868f22053aa
Category HUMAN OTC DRUG LABEL
Packager Bayer Healthcare LLC.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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

    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)

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    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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