ANTIBACTERIAL ANTIFUNGAL MEDICATED- chlorhexidine gluconate, ketoconazole spray

ANTIBACTERIAL ANTIFUNGAL MEDICATED by

Drug Labeling and Warnings

ANTIBACTERIAL ANTIFUNGAL MEDICATED by is a Animal medication manufactured, distributed, or labeled by Alpha Paw Inc, Tropichem Research Labs, LLC dba Vetio, Garonit Pharmaceutical, Inc, Unilab Chemicals and Pharmaceuticals Private Limited, Cadila Pharmaceuticals Limited, Piramal Pharma Limited, Sharon Bio-Medicine Limited. Drug facts, warnings, and ingredients follow.

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

ALPHA PAW
Questions or Comments:
Call (800) 363-5458
www.alphapaw.com
Alpha Paw LLC, Las Vegas NV 89139

Packaging

Package 237mL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ANTIFUNGAL MEDICATED 
chlorhexidine gluconate, ketoconazole spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86175-003
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)
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)

Product Characteristics
Color	orange (pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86175-003-16	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/03/2022

Labeler - Alpha Paw Inc (117036685)

Establishment
Name	Address	ID/FEI	Business Operations
Tropichem Research Labs, LLC dba Vetio		603123068	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Garonit Pharmaceutical, Inc		800875106	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Unilab Chemicals and Pharmaceuticals Private Limited		915893696	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Pharmaceuticals Limited		916130698	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Pharma Limited		919067108	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medicine Limited		675472749	api manufacture