Label: MEDICATED ANTIMICROBIAL- chlorhexidine gluconate and miconazole nitrate shampoo
- NDC Code(s): 51437-203-08, 51437-203-16, 51437-203-28
- 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 November 11, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
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INDICATIONS & USAGE
Uses: For dermatological conditions associated with infections responsive to Miconazole Nitrate and Chlorhexidine Gluconate.
Directions:
Wet coat thoroughly with water. Apply and lather Shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Repeat twice weekly until symptoms subside, then weekly, or as directed by your veterinarian.
- GENERAL PRECAUTIONS
- STORAGE AND HANDLING
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PRINCIPAL DISPLAY PANEL
Nootie
DERMATOLOGY
SOLUTIONS
Medicated
ANTIMICROBIAL SHAMPOO
ANTIFUNGAL AND ANTIBACTERIAL
Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%
FOR DOGS, CATS AND HORSES
8 fl oz (237ml) / 16 fl oz ( 474 ml) / 1 Gallon ( 3785 ml)
Nootie
Manufactured for and distributed by
Nootie LLC, 1 SE 4th Ave, Delray Beach, FL 33483
1-800-478-7713 Nootie.com
Product # SAB8 / # SAB16/ # GAB -
INGREDIENTS AND APPEARANCE
MEDICATED ANTIMICROBIAL
chlorhexidine gluconate and miconazole nitrate shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51437-203 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 MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51437-203-16 474 mL in 1 BOTTLE, PLASTIC 2 NDC:51437-203-08 237 mL in 1 BOTTLE, PLASTIC 3 NDC:51437-203-28 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2016 Labeler - Nootie, LLC (008995795)