Label: MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL- miconazole nitrate cream

  • NDC Code(s): 77338-041-25
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2% w/w

  • Purpose

    Anti-Fungal

  • Uses

    • For the treatment and prevention of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
    • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
  • Warnings

    For external use only

  • DO NOT USE

    on children under 2 years of age unless directed by Doctor

  • When using this product

    Avoid contact with eyes

  • Stop use and ask a doctor if

    irritation occurs

    there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

  • Keep out of reach of children

    In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

  • 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 healthcare professional • Supervise children in the use of this product.

    For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

    For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

    For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

    This product is not effective on the scalp or nails.

  • Other Information

    • Store at 15° - 30° c (59° - 86° f)

  • INACTIVE INGREDIENT

    Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    IMIDUREA (UNII: M629807ATL)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-041-25113 g in 1 TUBE; Type 0: Not a Combination Product08/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/22/2016
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-041)