Nootie HexZole Medicated Pet Flush: Product Information

NOOTIE HEXZOLE MEDICATED PET FLUSH- chlorhexidine gluconate and ketoconazole solution
Nootie 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.

Drug Facts

Active Ingredients:

Chlorhexidine Gluconate 0.2%
Ketoconazole 0.2%

Other Ingredients:

Purified Water, Propylene Glycol, Nonoxynol-12, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Polysorbate 20, Fragrance, Lactic Acid, Benzyl Alcohol.

Uses:

For topical skin conditions responsive to Chlorhexidine Gluconate and Ketoconazole.

Warnings:

› For animal use only.
› For topical use on dogs and cats.
› Avoid contact with eyes and mucous membranes.
› If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian.
› Keep out of reach of children.

Directions:

For use on ears, apply solution to the ear canal and with firm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any excess solution. For topical skin use, apply solution to the affected area and use a cotton ball to absorb any excess solution. Wash hands after application. Use once daily or as directed by your veterinarian.

Storage:

Store at room temperature (60 — 80°F). Protect from high temperatures. Protect from freezing.

Nootie ™ DERMATOLOGY SOLUTIONS

TOPICAL EAR & SKIN TREATMENT

HELPS TREAT AND RELIEVE:

› Hot Spots
› Ringworm
› Allergic Dermatitis
› Topical Ear & Skin Conditions

FOR DOGS AND CATS

√ Formulated with veterinarian strength active ingredients. √ Helps treat and manage ear and skin conditions responsive to Chlorhexidine and Ketoconazole.

MADE IN USA

Manufactured for and distributed by Nootie LLC
6421 Congress Ave., Suite 121, Boca Raton, FL 33487
1-800-478-7713 Nootie.com

Packaging

NOOTIE HEXZOLE MEDICATED PET FLUSH chlorhexidine gluconate, ketoconazole solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51437-107 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 2 mg in 1 mL KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL NONOXYNOL-12 GLYCERIN ALOE VERA LEAF POLYSORBATE 20 LACTIC ACID, UNSPECIFIED FORM BENZYL ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51437-107-08 237 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2022

Labeler — Nootie LLC (008995795)

Revised: 11/2022 Nootie LLC