MedPath

MiconaHex plus Triz

MiconaHex + Triz Shampoo

Approved
Approval ID

a5723832-bf9d-45ff-a3ea-92fc9cfa81a0

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Dechra Veterinary Products

DUNS: 362142734

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

chlorhexidine gluconate and miconazole nitrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17033-173
Product Classification
G
Generic Name
chlorhexidine gluconate and miconazole nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (2)

CHLORHEXIDINE GLUCONATEActive
Quantity: 20 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB
MICONAZOLE NITRATEActive
Quantity: 20 mg in 1 mL
Code: VW4H1CYW1K
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

SHAKE WELL BEFORE USING

MiconaHex+Triz®

Shampoo
2% Chlorhexidine Gluconate, USP
2% Miconazole Nitrate, USP

Formulated for dogs, cats and horses

Antimicrobial, antifungal, antibiofilm,
moisturizing

16 fl. oz. (473 mL)

Dechra

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 6/9/2025

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

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 6/9/2025

Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

VETERINARY INDICATIONS SECTION

LOINC: 50745-9Updated: 6/9/2025

For support of healthy skin for animals with conditions responsive to miconazole and/or chlorhexidine. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 6/9/2025

Also Contains: Decyl Polyglucoside, Water, Laureth 12, Cetrimonium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Hydroxide, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide I, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum), TrizEDTA® (Disodium EDTA; Tromethamine, USP), Oatmeal Extract, Aloe Vera Gel, PEG 150 Distearate

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/9/2025

Directions for Use: SHAKE WELL BEFORE EACH USE. Use in a ventilated area and prevent the animal from licking and ingesting the product during application or throughout the recommended contact time, as it may lead to gastrointestinal or respiratory tract irritation. Apply to wet coat, rub onto skin and haircoat to create a rich lather. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use up to 4 times per week or as directed by your veterinarian. All changes (positive or negative) in the condition of the skin and haircoat should be reported to your veterinarian to determine continued bathing frequency with this shampoo.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 6/9/2025

Store at room temperature.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/9/2025

Available through licensed veterinarians.

Not for human use.

Manufactured for: Dechra Veterinary Products
7015 College Blvd., Overland Park, KS 66211
866.933.2472
www.dechra-us.com

MHTW REV10/22

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