Label: LOTRIMIN AF ANTIFUNGAL- miconazole nitrate spray

  • 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 October 14, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (To Deliver) 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 unless directed by a doctor

    When using this product

    • avoid contact with the eyes
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
    • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures 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
  • Other information

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

  • Inactive ingredients

    dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)

  • Questions?

    1-866-360-3266

  • Distribution

    Distributed by Bayer HealthCare LLC

    Whippany, NJ 07981 USA

  • PRINCIPAL DISPLAY PANEL - 133 g Can Label

    Liquid Spray

    cools the burn

    NDC 11523-4327-01

    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 133 g

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN AF  ANTIFUNGAL
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4327
    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
    DIMETHYL ETHER (UNII: AM13FS69BX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4327-1133 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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