KAISER PERMANENTE MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [KAISER FOUNDATION HOSPITALS]

  • Home
  • KAISER PERMANENTE MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [KAISER FOUNDATION HOSPITALS]

KAISER PERMANENTE MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [KAISER FOUNDATION HOSPITALS]
PDF | XML
NDC 0179-8017-30
Set ID 3cc93bf1-7208-4152-b6d4-c77686d5206c
Category HUMAN OTC DRUG LABEL
Packager Kaiser Foundation Hospitals
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate USP 2%

  • Purpose

    Antifungal

  • Uses

    • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.
  • Warnings

    For external use only

    Do not use on children less than 2 years of age unless directed by a doctor

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • condition persists
    • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • 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
    • not effective on the scalp or nails
  • Other information

    • To open: unscrew cap, use pointed end on cap to puncture seal
    • store at 20° - 25°C (68° - 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1

    Distributed by
    Kaiser Foundation Hospitals
    Livermore, CA 94551-9756

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    KAISER PERMANENTE®

    Miconazole Nitrate Cream USP, 2%

    ANTIFUNGAL CREAM
    CURES MOST ATHLETE'S FOOT

    * Compare to the active ingredient in Micatin®

    NET WT 1 OZ (30 g)

    Principal Display Panel - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE  MICONAZOLE NITRATE
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8017
    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
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0179-8017-301 in 1 CARTON10/01/199105/31/2021
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/01/199105/31/2021
    Labeler - Kaiser Foundation Hospitals (053052619)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(0179-8017)
View All Sections

Related Drugs

Search DailyMed Drugs