Label: DAVIS MICONAZOLE- miconazole nitrate shampoo

  • NDC Code(s): 62570-070-01, 62570-070-12
  • Packager: Davis Manufacturing and Packaging Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 7, 2019

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  • DESCRIPTION

    Davis Miconazole Shampoo with 2% Miconazole Nitrate is specifically formulated for dermatological conditions associated with fungal infections such as ringworm, superficial skin infections caused by yeast and scaling due to seborrhea. Made with rich emollients, it penetrates the coat and skin and locks in needed moisture while helping to provide soothing relief. Davis Miconazole Shampoo is free from dyes and fragrances that could cause further irritation or reactions.

  • SPL UNCLASSIFIED SECTION

    MADE IN THE USA

     Davis Manufacturing

    541 Proctor Avenue

    Scottdale, GA 30079

    www.davismfg.com

    Product No. MS12   Rev 0712

  • ACTIVE INGREDIENT

    Active Ingredient: Miconazole Nitrate 2.0% 

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Colloidal Oatmeal, Ethylene Glycol Monostearate, Aloe Vera, PEG Distearate, Methylchloroisothiazolinone (and) Methylisothiazolinone

  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR USE Wet coat thoroughly with warm water. Apply shampoo to head and ears, then lather. Do not get shampoo into eyes. Repeat procedure with neck, chest, middle and hindquarter, finishing with legs. Allow shampoo to soak in for 10 minutes. To prevent ingestion, do not allow animal to lick while bathing. Rinse thoroughly with water. Repeat twice weekly until symptoms subside, then weekly, or as directed by a veterinarian.

  • SPL UNCLASSIFIED SECTION

    If desired follow the Davis Miconazole Shampoo bath with one using Davis Chlorhexidine Shampoo or make your own Miconazole/Chlorhexidine Shampoo by premixing Davis Miconazole shampoo and Davis Chlorhexidine Shampoo.

  • PRECAUTIONS

    Precautions: Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately contact your veterinarian.

  • PRINCIPAL DISPLAY PANEL

    Davis Veterinary Products
    Miconazole Shampoo
    With 2% Miconazole Nitrate
    For Dogs, Cats, Puppies and Kittens

    Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

    1 Gallon (3.785 Liters)

    MSG

  • PRINCIPAL DISPLAY PANEL

    Davis Veterinary Products
    Miconazole Shampoo
    With 2% Miconazole Nitrate
    For Dogs, Cats, Puppies and Kittens

    Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

    MS12

  • INGREDIENTS AND APPEARANCE
    DAVIS MICONAZOLE 
    miconazole nitrate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    OATMEAL (UNII: 8PI54V663Y)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62570-070-12355 g in 1 BOTTLE
    2NDC:62570-070-013785 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/14/2017
    Labeler - Davis Manufacturing and Packaging Inc (106680523)
    Registrant - Vanessa Solis (106680523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davis Manufacturing and Packaging inc106680523api manufacture
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