MICONAZOLE- miconazole nitrate shampoo 
GlenHaven LLC

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.

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Miconazole Shampoo

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: 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

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.

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

Available through licensed veterinarians only.

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
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)

Revised: 12/2021
Document Id: 2b7d3876-5791-4ee5-b3fc-d6e47a2c53e0
Set id: abf63136-b58f-4bd7-966d-762c09d7b9bc
Version: 3
Effective Time: 20211207
 
GlenHaven LLC