Label: PRIVATE LABEL ANTIFUNGAL BARRIER CREAM- 2% miconazole nitrate cream cream

  • NDC Code(s): 60232-0009-2, 60232-0009-4, 60232-0009-5
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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

  • Warnings

    For external use only. Not intended for ingestion. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the treatment of jock itch: if irritation occurs or there is no improvement within 2 weeks discontinue use and consult a doctor. Do not use for diaper rash. Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Use and Directions

    Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea sorporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

    Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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.

  • Keep out of reach of children

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

  • Active Ingredient

    Miconazole Nitrate 2.00%

  • PURPOSE

  • Inactive Ingredient

    Allantoin, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Fragrance, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide

  • Labeling

    PL009 Artwork

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL ANTIFUNGAL BARRIER CREAM 
    2% miconazole nitrate cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CUCUMBER (UNII: YY7C30VXJT)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0009-260 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
    2NDC:60232-0009-4120 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
    3NDC:60232-0009-5150 g in 1 TUBE; Type 0: Not a Combination Product11/22/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/22/2010
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0009)