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

  • 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 August 16, 2022

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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 finalpart333C03/22/2016
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-041)