Label: NOOTIE- chlorhexidine gluconate, ketoconazole shampoo
- NDC Code(s): 51437-561-04, 51437-561-16
- Packager: Nootie LLC
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 Label Information
Updated December 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients:
- Other Ingredients:
- Uses:
- Warnings:
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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:
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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 ConditionsFOR 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
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INGREDIENTS AND APPEARANCE
NOOTIE
chlorhexidine gluconate, ketoconazole shampooProduct 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)