Label: ANTIFUNGAL- miconazole nitrate cream

  • NDC Code(s): 67777-710-01, 67777-710-02, 67777-710-03, 67777-710-04, view more
    67777-710-05
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 17, 2026

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  • Active ingredient

    Miconazole Nitrate USP 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruis), and ringworm (tinea corporis)

    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, and itching, burning feet.

  • Warnings

    For External Use Only

    Do not use

    • On children under 2 years of age unless directed by a doctor

    • Avoid contact with eyes

    Stop use and ask a doctor if

    • Irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor for athlete's foot and ringworm.

    • Irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor for jock itch.

    Keep out of reach of children

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

  • Directions

    • Clean the affected area and dry thoroughly. Apply a thin layer 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.

  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F)

    • Tamper evident. Do not use if seal is damaged.

  • 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, zinc oxide

  • Questions?

    1-888-Dynarex Monday-Friday, 9am-5pm EST

  • Label 1230-MN

    1230-MN_BX_MASTER

  • Label 1233-MN

    1233-MN_IN_MASTER

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-710
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-710-022 in 1 CASE03/24/2026
    1NDC:67777-710-01144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-710-054 in 1 CASE03/24/2026
    2NDC:67777-710-046 in 1 BOX
    2NDC:67777-710-03113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/24/2026
    Labeler - Dynarex Corporation (008124539)
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