NOOTIE- chlorhexidine gluconate, ketoconazole shampoo

Nootie by

Drug Labeling and Warnings

Nootie by is a Animal medication manufactured, distributed, or labeled by Nootie LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Chlorhexidine Gluconate 2%

Ketoconazole 1%

Other Ingredients:

Purified Water, Lauramine Oxide, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

Uses:

For dermatological 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:

Wet coat thoroughly with water. Apply a sufficient amount of shampoo to massage into a rich lather all over the body. Allow lather to stay on skin for 5 to 8 minutes, then rinse completely. Do not allow animal to lick while bathing to prevent ingestion. For best results, use 2-3 times weekly until symptoms subside or as directed by veterinarian.

Storage:

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

SPL UNCLASSIFIED SECTION

Nootie™ DERMATOLOGY SOLUTIONS

SKIN CONDITION TREATMENT

HELPS TREAT AND RELIEVE:

› Hot Spots & Ringworm
› Skin Infections
› Dry Itchy Skin
› Allergic Dermatitis
› Topical Skin Conditions

FOR DOGS AND CATS

√  Formulated with veterinarian strength active ingredients.
√  Helps treat and manage 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

INGREDIENTS AND APPEARANCE

NOOTIE 
chlorhexidine gluconate, ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51437-561
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51437-561-04	118 mL in 1 BOTTLE
2	NDC: 51437-561-16	474 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2022

Labeler - Nootie LLC (008995795)