LOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [BAYER HEALTHCARE LLC.]

  • Home
  • LOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [BAYER HEALTHCARE LLC.]

LOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [BAYER HEALTHCARE LLC.]
PDF | XML
NDC 11523-4327-1
Set ID d6eb3b78-405b-43e5-9db5-da671465eda1
Category HUMAN OTC DRUG LABEL
Packager Bayer Healthcare LLC.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs