MALASEB (CHLORHEXIDINE GLUCONATE, MICONAZOLE NITRATE) SHAMPOO [BAYER HEALTHCARE LLC]

MALASEB (CHLORHEXIDINE GLUCONATE, MICONAZOLE NITRATE) SHAMPOO [BAYER HEALTHCARE LLC]
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NDC 0859-3016-03, 0859-3016-04, 0859-3016-05, 0859-3016-06
Set ID 2674b87b-5ba8-4c35-871c-3df3a04d6a00
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Bayer HealthCare LLC
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • KEY INGREDIENTS:

    Miconazole Nitrate 2%, Chlorhexidine Gluconate 2%.

  • PRODUCT DESCRIPTION:

    Malaseb® Shampoo combines a unique formulation of chlorhexidine gluconate and miconazole nitrate with coat conditioners. The fragrance-free shampoo base descales and degreases the hair coat without stripping.

  • INDICATIONS:

    For dermatological conditions responsive to miconazole nitrate and chlorhexidine gluconate.

  • DIRECTIONS:

    Wet coat thoroughly with water. Apply and lather Malaseb® Shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Use weekly or as directed by your veterinarian.

  • CAUTIONS:

    For topical use on dogs, cats and horses. Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian.

  • STORAGE:

    Store at room temperature. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Bayer HealthCare LLC, Animal Health Division
    Shawnee Mission, KS 66201

    Made in Canada

    Bayer, the Bayer Cross and DVM & Design are registered trademarks of Bayer.

    Malaseb is a registered trademark of Dermcare-Vet Pty. Ltd.

    ©2019 Bayer LV1908

  • Package/Label Principal Display Panel

    Malaseb Shampoo (2% Clorihexidine Gluconate, 2% Miconazole Nitrate) label

    Malaseb®
    Shampoo

    Shampoo Formulation
    for Dogs, Cats and Horses

    2% Chlorhexidine Gluconate
    2% Miconazole Nitrate

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    WARNING: Keep out of reach of children. | Shampoo

    NET CONTENTS: 237 mL (8 fl oz)

  • INGREDIENTS AND APPEARANCE
    MALASEB 
    chlorhexidine gluconate, miconazole nitrate shampoo
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0859-3016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 g  in 1 L
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-3016-051.89 L in 1 BOTTLE, PLASTIC
    2NDC:0859-3016-030.237 L in 1 BOTTLE, PLASTIC
    3NDC:0859-3016-060.473 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other09/09/2014
    Labeler - Bayer HealthCare LLC (152266193)

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