Label: DAVIS MICONAZOLE- miconazole nitrate spray

  • NDC Code(s): 62570-071-04, 62570-071-16
  • Packager: Davis Manufacturing and Packaging Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 17, 2018

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Davis Miconazole Spray with 2% Miconazole Nitrate helps provide relief for dermatological conditions associated with fungal infections such as ringworm, superficial skin infections caused by yeast and scaling die to seborrhea. Davis Miconazole Spray is free from dyes and fragrances that could cause further irriration or reactions and is safe for use on dogs, cats, puppies, kittens and horses.

    Close
  • SPL UNCLASSIFIED SECTION

    Made in The USA

    Manufactured by:

    Davis Manufacturing and Packaging

    541 Proctor Avenue

    Scottdale, GA 30079

    www.davismfg.com

    Close
  • ACTIVE INGREDIENT

    Active Ingredients: 2% Miconazole Nitrate

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients: Polyethylene Glycol, Ethanol, Polysorbate, Butylated Hydroxytoluene, Vitamin E

    Close
  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR USE

    Shake well before using. Spray a thin layer directly on affected areas twice daily or as directed by a veterinarian.

    Close
  • PRECAUTIONS

    Precautions

    For topical use only on dogs, cats, and horses. Not for use for animals intended for food. Avoid contact with eyes and mucous membranes. Discontinue use if skin becomes irritated or inflamed.

    For External Use Only

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Close
  • PRINCIPAL DISPLAY PANEL

    Davis Vererinary Products

    Miconazole Spray

    With 2% Miconazole Nitrate

    For Dogs, Cats, Horses

    For the management of conditions associated with fungal infections

    4 Fl. Oz (188.56)

    4 oz MS

    Close
  • Principal Display Panal 16 oz

    Davis Vererinary Products

    Miconazole Spray

    With 2% Miconazole Nitrate

    For Dogs, Cats, Horses

    For the management of conditions associated with fungal infections

    16 Fl Oz. (473.2 ml)

    16 oz

    Close
  • INGREDIENTS AND APPEARANCE
    DAVIS MICONAZOLE 
    miconazole nitrate spray
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:62570-071
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62570-071-04 118.56 g in 1 BOTTLE, SPRAY
    2 NDC:62570-071-16 473.2 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/14/2017
    Labeler - Davis Manufacturing and Packaging Inc (106680523)
    Registrant - Vanessa Solis (106680523)
    Establishment
    Name Address ID/FEI Business Operations
    Davis Manufacturing and Packaging 106680523 api manufacture
    Close