Label: MEDICATED ANTIMICROBIAL- chlorhexidine gluconate and miconazole nitrate shampoo

  • NDC Code(s): 51437-203-08, 51437-203-16, 51437-203-28
  • Packager: Nootie, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 11, 2021

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  • Drug Facts

    Active Ingredients:                        Purpose
    Chlorhexidine Gluconate (2%)           Antibacterial
    Miconazole Nitrate (2%)                   Antifungal

  • INDICATIONS & USAGE

    Uses: For dermatological conditions associated with infections responsive to Miconazole Nitrate and Chlorhexidine Gluconate.

    Directions:

    Wet coat thoroughly with water. Apply and lather 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. Repeat twice weekly until symptoms subside, then weekly, or as directed by your veterinarian.

  • GENERAL PRECAUTIONS

    Warnings:

    • For animal use only
    • 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 AND HANDLING

    Storage: Store at room temperature (59°F-86°)

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Nootie

    DERMATOLOGY

    SOLUTIONS

    Medicated

    ANTIMICROBIAL SHAMPOO

    ANTIFUNGAL AND ANTIBACTERIAL

    Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%

    FOR DOGS, CATS AND HORSES

     8 fl oz (237ml) / 16 fl  oz ( 474 ml) /  1 Gallon ( 3785 ml)

    Nootie
    Manufactured for and distributed by
    Nootie LLC, 1 SE 4th Ave, Delray Beach, FL 33483
    1-800-478-7713 Nootie.com
    Product # SAB8 / # SAB16/ # GAB

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  • INGREDIENTS AND APPEARANCE
    MEDICATED ANTIMICROBIAL 
    chlorhexidine gluconate and miconazole nitrate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51437-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51437-203-16474 mL in 1 BOTTLE, PLASTIC
    2NDC:51437-203-08237 mL in 1 BOTTLE, PLASTIC
    3NDC:51437-203-283785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2016
    Labeler - Nootie, LLC (008995795)
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