Label: MICONAZOLE- miconazole nitrate shampoo

  • 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 January 24, 2020

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

  • 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
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    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)