Label: LOTRIMIN ANTIFUNGAL- miconazole nitrate powder

  • NDC Code(s): 11523-0919-1
  • Packager: MSD Consumer care, Inc.
  • 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 02/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Miconazole nitrate 2%

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  • Purpose

    Antifungal

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  • Uses

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

    For external use only

    Avoid contact with the eyes

    Stop use and ask a doctor if irritation occurs or if 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 unless directed by a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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
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  • Other information

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

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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    © Copyright & Distributed by MSD Consumer Care, Inc.,
    PO Box 377, Memphis, TN 38151 USA, a subsidiary of
    Merck & Co., Inc., Whitehouse Station, NJ USA.

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  • 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

    Principal Display Panel - 90g Can Label
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  • INGREDIENTS AND APPEARANCE
    LOTRIMIN   ANTIFUNGAL
    miconazole nitrate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-0919
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole nitrate (Miconazole) Miconazole nitrate 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    benzethonium chloride  
    starch, corn  
    kaolin  
    sodium bicarbonate  
    zinc oxide  
    Product Characteristics
    Color WHITE (White to off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-0919-1 90 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 09/01/1993
    Labeler - MSD Consumer care, Inc. (968091715)
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