Label: MICONAZOLE- miconazole nitrate shampoo

  • Category: OTC ANIMAL DRUG LABEL

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 December 7, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • VETERINARY INDICATIONS

    Miconazole Shampoo is an antifungal shampoo which promotes healthy skin for animals with conditions responsive to miconazole. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

  • DESCRIPTION

    ACTIVE INGREDIENT: 2% Miconazole Nitrate, USP

  • DESCRIPTION

    ALSO CONTAINS: Water, Sodium C14-16 Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Laureth Sulfate, Glycol Stearate, Fragrance, Glycerine, Sodium Lactate, Tetrasodium EDTA, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Shake bottle before each use. After wetting or bathing your pet massage Miconazole Shampoo into your pet's wet coat until lightly lathered. Leave on pet for 5-10 minutes, then rinse thoroughly. Use initially 2-4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian. For best results follow with GlenHaven Miconazole Conditioner.

  • SAFE HANDLING WARNING

    CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use or call your veterinarian. Keep out of reach of children and pets. Wash hands after use.

  • STORAGE AND HANDLING

    STORAGE: Store at controlled room temperature of 20-25° C (68-77° F).

  • INFORMATION FOR OWNERS/CAREGIVERS

    Available through licensed veterinarians only.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    GlenHaven
    18101 SE 6th Way
    Vancouver, WA 98683

    53239 REV02/19

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    NDC 70782-101-12

    GlenHaven™
    Therapeutics

    Miconazole
    Shampoo

    Formerly F2/S

    Antiseptic, antifungal

    2% Miconazole Nitrate, USP

    For Dog and Cat Use Only

    Net Contents: 12 FL OZ. (355 mL)

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    miconazole nitrate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:70782-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70782-101-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2016
    Labeler - GlenHaven LLC (002542300)
    Registrant - Dechra Veterinary Products (362142734)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!