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Animal NDC 70782-101-12 Miconazole

Miconazole Nitrate

Animal Product Information

Field Name Field Value
Animal NDC Code 70782-101-12
Proprietary Name Miconazole What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Miconazole Nitrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Glenhaven Llc
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Miconazole Nitrate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Miconazole Images

Miconazole Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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

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.


Other



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)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.