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FDA Approval

MiconaHex plus Triz

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dechra Veterinary Products
DUNS: 362142734
Effective Date
June 6, 2025
Labeling Type
OTC ANIMAL DRUG LABEL
Chlorhexidine(20 mg in 1 mL)
Miconazole(20 mg in 1 mL)

Products1

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

MiconaHex plus Triz

Product Details

NDC Product Code
17033-175
Route of Administration
TOPICAL
Effective Date
June 6, 2025
Code: MOR84MUD8EClass: ACTIBQuantity: 20 mg in 1 mL
Code: VW4H1CYW1KClass: ACTIBQuantity: 20 mg in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


DESCRIPTION SECTION

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


VETERINARY INDICATIONS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

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

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


STORAGE AND HANDLING SECTION

Store at room temperature.


SPL UNCLASSIFIED SECTION

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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