Label: ANTIBACTERIAL ANTIFUNGAL - ketoconazole and chlorhexidine gluconate shampoo
- NDC Code(s): 43369-039-01
- Packager: FidoPharmBrands, LLC
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
LABEL FRONT PANELFROM THE MAKERS OF
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• Cleans and disinfects as an aid against
bacterial and fungal infections
• Kills bacteria
• Non-irritating, alcohol free
2% Chlorhexidine Gluconate
FOR DOGS AND CATS
8 FL OZ (236mL)
From the makers of PetArmor®, VetTrust™ Antibacterial AntifungalClose
Shampoo is a dual-action shampoo that helps fight bacterial and
fungal infections. It combines two ingredients known to help fight
bacteria, yeast, and fungal infections while also cleaning your dog or
cat. Use as directed to help restore your pet’s healthy skin and soft
shiny coat. Its fresh scent also leaves your pet smelling great!
- ACTIVE INGREDIENT
ACTIVE INGREDIENTS: 2.0% CHLORHEXIDINE GLUCONATE,Close
- INACTIVE INGREDIENT
INACTIVE INGREDIENTS: PURIFIED WATER, LAURAMINE OXIDE,Close
COCAMIDOPROPYL BETAINE, POLYACRYLATE-1 CROSSPOLYMER, DISODIUM
OLEAMIDO MIPA SULFOSUCCINATE, GLYCOLIC ACID, ALOE BARBADENSIS
(ALOE VERA) LEAF JUICE, FRAGRANCE, METHYLCHLOROISOTHIAZOLINONE
(AND) METHYLISOTHIAZOLINONE, CITRIC ACID.
- INSTRUCTIONS FOR USE
Directions for Use: SHAKE WELL. Apply to wet coat, rub onto skin andClose
haircoat to create a rich lather. Allow shampoo to remain on skin and coat
for 5-10 minutes. Rinse well. Use initially 2-4 times per week for 4 weeks,
then reduce to once per week or as directed by veterinarian.
- STORAGE AND HANDLING
Store at controlled room temperature of 15 - 30° C (59 - 86° F).Close
Caution: For topical use only. Avoid contact with eyes. If skin irritation developsClose
or increases or you see no improvement, stop use and call your veterinarian. Keep
out of the reach of children and pets. Wash hands after use.
Questions? Comments? 1-855-908-PETS (7387)MADE IN USA
Distributed by FidoPharm
PO Box 1060, Yardley, PA 19067-9060
©2012 FidoPharmBrands, LLC. All rights reserved.
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ketoconazole, chlorhexidine gluconate shampoo
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:43369-039 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 2.36 mg in 1 mL CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4.7 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43369-039-01 236 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/04/2013 Labeler - FidoPharmBrands, LLC (078346506) Registrant - FidoPharmBrands, LLC (078346506) Establishment Name Address ID/FEI Business Operations TropiChem 603123068 manufacture Establishment Name Address ID/FEI Business Operations NetQem, LLC 362973500 api manufacture