Label: NOOTIE- chlorhexidine gluconate, ketoconazole shampoo

  • NDC Code(s): 51437-561-04, 51437-561-16
  • Packager: Nootie LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 7, 2022

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  • Drug Facts

  • Active Ingredients:

    Chlorhexidine Gluconate 2%

    Ketoconazole 1%

  • Other Ingredients:

    Purified Water, Lauramine Oxide, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

  • Uses:

    For dermatological conditions responsive to Chlorhexidine Gluconate and Ketoconazole.

  • Warnings:

    › For animal use only.
    › For topical use on dogs and cats.
    › 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.
    › Keep out of reach of children.

  • Directions:

    Wet coat thoroughly with water. Apply a sufficient amount of shampoo to massage into a rich lather all over the body. Allow lather to stay on skin for 5 to 8 minutes, then rinse completely. Do not allow animal to lick while bathing to prevent ingestion. For best results, use 2-3 times weekly until symptoms subside or as directed by veterinarian.

  • Storage:

    Store at room temperature (60 - 80°F). Protect from high temperatures. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Nootie™ DERMATOLOGY SOLUTIONS

    SKIN CONDITION TREATMENT

    HELPS TREAT AND RELIEVE:

    › Hot Spots & Ringworm
    › Skin Infections
    › Dry Itchy Skin
    › Allergic Dermatitis
    › Topical Skin Conditions

    FOR DOGS AND CATS

    √  Formulated with veterinarian strength active ingredients.
    √  Helps treat and manage skin conditions responsive to Chlorhexidine and Ketoconazole.

    MADE IN USA

    Manufactured for and distributed by
    Nootie LLC, 6421 Congress Ave., Suite 121, Boca Raton, FL 33487
    1-800-478-7713 Nootie.com

  • Packaging

    Nootie-561

  • INGREDIENTS AND APPEARANCE
    NOOTIE 
    chlorhexidine gluconate, ketoconazole shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51437-561
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51437-561-04118 mL in 1 BOTTLE
    2NDC:51437-561-16474 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/11/2022
    Labeler - Nootie LLC (008995795)
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