Label: BAZA ANTIFUNGAL- miconazole nitrate cream

  • NDC Code(s): 11701-045-14, 11701-045-22, 11701-045-23
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 14, 2018

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

  • SPL UNCLASSIFIED SECTION

    For Perineal
    Skin Irritation Due to
    Fungal Infection

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active ingredient

    Miconazole Nitrate, 2%

    Purpose

    Antifungal

    Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.

    Warnings

    When using this product

    • avoid contact with eyes
    • do not use on children under 2 years of age unless directed by a doctor.

    Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.

    For external use only.

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

    Directions

    • clean the affected area and dry thoroughly
    • apply thin layer of product over affected area twice daily (morning and night), or as directed by a doctor
    • supervise children in the use of this product.

    Use daily for 2 weeks.

    If condition persists, consult a doctor. This product is not effective on scalp or nails.

    Inactive ingredients

    BHT, cetearth-6, cetyl alcohol, cod liver oil, diazolidinyl urea, fragrance, glyceryl stearate, lanolin oil, PEG-100 stearate, petrolatum, polmethoxybicyclic oxazolidine, propylene glycol, water, stearyl alcohol, tocopheryl acetate, zinc oxide

    See crimp for lot no. and expiration date

    Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
    Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
    1-800-533-0464 www.us.coloplast.com
    Product #1607 ©2008-7, Coloplast Corp.
    Made in the U.S.A.

    G8-664

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142 g)

    NDC 11701-045-14

    Baza®Antifungal

    Antifungal

    Moisture Barrier Antifungal Cream

    For Perineal Skin Irritation Due to Fungal Infection

    Coloplast

    NET WT. 5 OZ. (142 g)

    PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)
  • INGREDIENTS AND APPEARANCE
    BAZA ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-045
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CETEARETH-6 (UNII: 2RJS3559D3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-045-224 g in 1 PACKET; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-045-2357 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    3NDC:11701-045-14142 g in 1 TUBE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-045)