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Baza Antifungal (Coloplast Manufacturing US, LLC)

Available Formats

Dosage Form Package Information Links
CREAM 142 g in 1 TUBE (11701-045-14) Label Information
CREAM 57 g in 1 TUBE (11701-045-23) Label Information
CREAM 4 g in 1 PACKET (11701-045-22) Label Information

Complete Baza Antifungal Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:11701-045
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11701-045-22 4 g in 1 PACKET; Type 0: Not a Combination Product 06/15/2009
    2 NDC:11701-045-23 57 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009
    3 NDC:11701-045-14 142 g in 1 TUBE; Type 0: Not a Combination Product 06/15/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    Name Address ID/FEI Business Operations
    Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-045)