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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Anti-Fungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
  • Warnings

    For external use only. Do not use if the safety-sealed tube is punctured or damaged.

    Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes.

    Stop use and ask a doctor if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

  • Other information

    Distributed by:
    Rugby Laboratories

    Indianapolis, IN. 46268

    800-616-2471

    www.majorpharmaceuticals.com

    This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.

  • 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 doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.

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

    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.

  • INACTIVE INGREDIENT

    Inactive ingredientsCarbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.

  • Other Information

    • Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

  • Packaging

    Rugby Miconazole Cream 1oz CDER

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1375
    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)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LAURETH-30 (UNII: W9D845551A)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1375-751 in 1 BOX02/07/2023
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/07/2023
    Labeler - Rugby (079246066)
    Registrant - Trifecta Pharmaceuticals USA (079424163)