Label: MACERRX WEB- miconazole nitrate cream

  • NDC Code(s): 44577-205-56
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Active Ingredient:

    -Miconazole Nitrate 2.00%

    Antifungal

  • Uses:

    Proven clinically to cure most:

    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis) Effectively soothese and relieves:
    • itching
    • burning
    • cracking
    • Helps prevent most athlete’s foot from coming back with daily use
    • For the treatment of superficial skin infections caused by yeast (Candida albicans, intertrigo) and erythrasma
  • Warnings:

    • For external use only

    When using this product:

    • Avoid contact with eyes

    Stop use and ask a doctor if:

    • Irritation occurs
    • There is no improvement within 4 weeks

    Keep out of reach of children.

    If swallowed, contact physician or poison control center immediately.

    Store at room

    temperature 68-77ºF (20-25º C)

  • Directions:

    • clean the affected area and dry thoroughly
    • apply a thin layer over the affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete’s foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • use daily for 4 weeks. If condition lasts longer, ask a doctor
    • to prevent athlete’s foot, apply to the feet once or twice daily
    • this product is not effective on the scalp or nails
  • Other Ingredients:

    Acetic Acid, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree Oil), Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol, Triethanolamine

  • Package Labeling:

    Label00

  • INGREDIENTS AND APPEARANCE
    MACERRX WEB 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-205
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-205-561 in 1 CARTON02/06/2017
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/06/2013
    Labeler - Clinical Therapeutic Solutions (078402750)
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