ANTIBACTERIAL ANTIFUNGAL MEDICATED- chlorhexidine gluconate, ketoconazole spray

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

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

PURPOSE

ANTIBACTERIAL & ANTIFUNGAL MEDICATED SPRAY For Dogs & Cats

DITCH THE ITCH!

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

INACTIVE INGREDIENTS

Water, Glycerine, Propylene Glycol, Polysorbate 20, Lactic Acid, PEG-75 Lanolin, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Fragrance, Methylisothiazolinone.

PRECAUTIONS

For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. If undue skin irritation develops or increases, discontinue use and consult a veterinarian

DIRECTIONS

Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow animal to lick the treated areas until
dry to prevent ingestion.

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 spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86255-005
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86255-005-01	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 86255-005-02	118 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)