Label: DB ANTIFUNGAL FOOT- miconazole nitrate cream

  • NDC Code(s): 43689-0025-1, 43689-0025-2
  • Packager: The Magni Group Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active ingredients (in cream)

    Miconazole Nitrate 2%

    Purpose

    Antifungal

  • Uses

    • Cures most tinea pedis (athlete’s foot) • Relieves itching, scaling, cracking, burning, redness; itchy, scaly skin between toes; itching, burning feet; discomfort

  • Warnings

    Do not use

    • on children under 2 years of age unless directed by a doctor • For external use only
    • Avoid contact with the eyes 
    • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor

    Keep out of reach of children

    • If swallowed, get medical attention, help, or contact a poison control center right away

  • Directions

    • Wash 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 • If condition persists longer, consult a doctor • This product is not effective on the scalp or nails

  • Inactive ingredients

    Allium Sativum Garlic (Plant) Extract, C12-15 Alkyl Benzoate, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Hydroxyacetophenone, Isopropyl Palmitate, Isopropyl Myristate, Lemon Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Acrylate/Sodium Acryldimethyl Taurate Copolymer, Tocopheryl Acetate, Water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DB ANTIFUNGAL FOOT 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0025
    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
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LEMON OIL (UNII: I9GRO824LL)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0025-1113 g in 1 JAR; Type 0: Not a Combination Product04/27/2017
    2NDC:43689-0025-21 in 1 BOX04/27/2017
    2113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/27/2017
    Labeler - The Magni Group Inc (113501902)
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