ANTIBACTERIAL ANTIFUNGAL MEDICATED- chlorhexidine gluconate, ketoconazole shampoo

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

Chlorhexidine Gluconate...............................2%
Ketoconazole..................................................1%

PURPOSE

ANTIBACTERIAL & ANTIFUNGAL MEDICATED SHAMPOO For Dogs & Cats

DITCH THE ITCH!

Kiss itch and irritation goodbye for your scratchy pets. Treatment is as easy as lather, rinse and soothe. Skin conditions that are responsive to Ketoconazole and Chlorhexidine stand no chance against this powerful formula. Vitamin E and essential fatty acids follow close behind to ensure that treated skin is nourished.

INACTIVE INGREDIENTS

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

PRECAUTIONS

Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Not for otic use. Wash hands after using.

DIRECTIONS

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow shampoo to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

CAUTIONS

If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

STORAGE

Store at controlled room temperature.

SPL UNCLASSIFIED SECTION

Contains chlorhexidine & ketoconazole
Freshens & deodorizes
Treatment for dry, itchy irritated skin
Removes yeast, bacteria, fungus & ringworm

GENTLE ON SKIN
CHOSEN BY TOP VETS
FOR DOGS AND CATS

Smiling Paws Pets
5924 Sheridan St
Hollywood, FL 33021
www.smilingpawspets.com

Product label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ANTIFUNGAL MEDICATED 
chlorhexidine gluconate, ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86255-003
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86255-003-01	1 in 1 PACKAGE
1		355 mL in 1 BOTTLE, PLASTIC
2	NDC: 86255-003-02	1 in 1 PACKAGE
2		473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2024

Labeler - Smiling Paws Pets LLC (838142813)