Label: LOTRIMIN ANTIFUNGAL- miconazole nitrate powder

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, cracking, burning and scaling
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • if 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
    • sprinkle 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
  • Other information

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

  • Inactive ingredients

    benzethonium chloride, corn starch, kaolin, sodium bicarbonate, starch/acrylates/acrylamide copolymer, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 90g Can Label

    NDC 11523-0919-1

    LOTRIMIN®AF

    ANTIFUNGAL

    miconazole nitrate

    Cures Most

    Athlete's Foot

    POWDER

    • Absorbs Moisture
    • Relieves Itching,

      Burning & Scaling

    NET WT 90g (3 OZ)

    37871-00

    Lotrimin AF Powder 0919 FrontLotrimin AF Powder 0919 Back

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN  ANTIFUNGAL
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0919
    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
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Product Characteristics
    Colorwhite (White to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0919-190 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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