MedPath

MiconaHex plus Triz

MiconaHex+Triz Shampoo

Approved
Approval ID

d03fee79-3529-4172-8506-332e8049234b

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Jun 6, 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 Code17033-175
Product Classification
G
Generic Name
Chlorhexidine Gluconate and MICONAZOLE NITRATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 6, 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: 6/6/2025

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

VETERINARY INDICATIONS SECTION

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

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: 6/6/2025

Active Ingredients: 2% Chlorhexidine Gluconate, USP; 2% Miconazole Nitrate, USP

Also Contains: Water, Lauramine Oxide, Lactic Acid, Cocamidopropyl Betaine, Decyl Glucoside, Polyacrylate-1 Crosspolymer, TrizEDTA® (Tromethamine, USP; Disodium EDTA, USP), Lavender Oil, Lemongrass Oil, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum), Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone

DOSAGE & ADMINISTRATION SECTION

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

Directions for Use: SHAKE WELL BEFORE EACH USE. 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.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/6/2025

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: 6/6/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/6/2025

Store at room temperature.

SPL UNCLASSIFIED SECTION

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

Available through licensed veterinarians.

For Veterinary Use Only.

Manufactured for:
Dechra Veterinary Products
7015 College Blvd.
Overland Park, KS 66211
(866) 933-2472

www.dechra-us.com

16MHTW REV09/23-V

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MiconaHex plus Triz - FDA Drug Approval Details