MICONAZOLE- miconazole nitrate shampoo

Miconazole by

Drug Labeling and Warnings

Miconazole by is a Animal medication manufactured, distributed, or labeled by GlenHaven LLC, Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

MICONAZOLE 
miconazole nitrate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 70782-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70782-101-12	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2016

Labeler - GlenHaven LLC (002542300)

Registrant - Dechra Veterinary Products (362142734)