NOOTIE- chlorhexidine gluconate, ketoconazole shampoo 
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.

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Nootie™ HexZole Medicated Pet Shampoo

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.

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

Nootie-561

NOOTIE 
chlorhexidine gluconate, ketoconazole shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51437-561
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51437-561-04118 mL in 1 BOTTLE
2NDC:51437-561-16474 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/11/2022
Labeler - Nootie LLC (008995795)

Revised: 12/2022
Document Id: a9021876-7cf9-4295-802a-0b28e4051154
Set id: 7768035f-55c8-4f7f-850f-f7714c7a3f08
Version: 4
Effective Time: 20221207
 
Nootie LLC