Label: MICONAZOLE NITRATE ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 12, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Uses

    For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
    and chafing associated with jock itch or itching, burning feet

  • Warnings For External Use Only

    Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
    When using this product Avoid contact with the eyes
    Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
    improvement within 4 weeks when used for athlete's foot and ringworm
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    Do not use On children under 2 years of age unless directed by a
    doctor For diaper rash.

    When using this product Avoid contact with the eyes

  • Stop use and ask a doctor if

    Stop use and ask a doctor if Irritation occurs There is no
    improvement within 2 weeks when used for the treatment of jock

    itch There is no improvement within 4 weeks when used for athlete's
    foot and ringworm

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center right away.

  • Other Information

    Do not use if seal on the tube is damaged or
    is not visible. To open, unscrew cap, pull tab to remove foil seal See
    crimp of tube or carton for Lot Number and Expiry Date Preserve in
    well-closed containers, and store controlled room temperature

  • Inactive Ingredients

    Inactive Ingredients Cetostearyl Alcohol, Chlorocresol, Edetate
    Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene
    Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium
    Phosphate Monobasic Dihydrate, White Petrolatum

  • Active Ingrediant

    Miconazole Nitrate 2%

  • WARNINGS FOR EXTERNAL USE ONLY

    Miconazole Nitrate 2%

    For External Use Only
    Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
    When using this product Avoid contact with the eyes
    Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
    improvement within 4 weeks when used for athlete's foot and ringworm
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS AND USES

    Uses
    For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
    and chafing associated with jock itch or itching, burning feet

    Clean the affected area and dry thoroughly Apply a thin layer of the cream 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

  • PURPOSDE

    Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal

  • PRINCIPAL DISPLAY PANEL

    miconazole

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84387-003
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84387-003-0128.4 g in 1 TUBE; Type 0: Not a Combination Product10/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/25/2024
    Labeler - ALLIED TRADE LINK LLC (029033682)
    Registrant - ALLIED TRADE LINK LLC (029033682)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOPALDAS VISRAM AND COMPANY LMITED858030888manufacture(84387-003)