SEBOZOLE- miconazole nitrate, salicylic acid, and chloroxylenol shampoo

Sebozole by

Drug Labeling and Warnings

Sebozole by is a Animal medication manufactured, distributed, or labeled by Vetoquinol USA, Inc., American Pharmaceuticals and Cosmetics, Inc., N.S.Chemicals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Vetoquinol Sebozole™ Shampoo is uniquely formulated to provide antimicrobial, antifungal and antiseborrheic agents for optimal therapeutic effectiveness.

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Miconazole Nitrate 2%, Salicylic Acid 2%, Chloroxylenol 1%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Purified Water, Sodium Olefin Sulfonate, Polyethylene Glycol 150 Pentaerythrityl Tetrastearate, Lauramide DEA, Propylene Glycol, Sodium Thiosulfate, Carbopol, Sodium Hydroxide, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, Blue 1.

INDICATIONS & USAGE

INDICATIONS FOR USE: For dermatological conditions associated with infections responsive to Miconazole Nitrate and Chloroxylenol.

DOSAGE & ADMINISTRATION

DIRECTIONS: Shake well. With tepid water, thoroughly wet animal's coat. Apply and lather shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Repeat twice weekly until symptoms subside, then weekly, or as directed by veterinarian.

PRECAUTIONS

CAUTION: For topical use only on dogs, cats and horses. Avoid contact with eyes. Keep out of reach of children. Store at room temperature. If irritation develops, discontinue and consult your veterinarian.

KEEP OUT OF REACH OF CHILDREN AND PETS.
FOR ANIMAL USE ONLY.

SPL UNCLASSIFIED SECTION

Distributed by Vetoquinol USA Inc.
Ft. Worth, TX (USA) 76137
www.vetoquinolusa.com
1 (800) 267-5707

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 17030-013-16

vetoquinoL

SEBOZOLE™
SHAMPOO

Deep Cleaning, Antimicrobial

2% Miconazole Nitrate, 2% Salicylic Acid, 1% Chloroxylenol.
Antimicrobial, Antifungal and Antiseborrheic for Dermatological
Conditions Responsive to Miconazole Nitrate, Salicylic Acid and
Chloroxylenol.

ANTIFUNGAL

YEAST/
BACTERIA

DRY/FLAKY

NET CONTENTS: 16 fl oz (473mL)

INGREDIENTS AND APPEARANCE

SEBOZOLE 
miconazole nitrate, salicylic acid, and chloroxylenol shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17030-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	20 mg  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
PEG-150 Pentaerythrityl Tetrastearate (UNII: 8L4OOQ76AM)
Lauric Diethanolamide (UNII: I29I2VHG38)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Thiosulfate (UNII: HX1032V43M)
Carboxypolymethylene (UNII: 0A5MM307FC)
Sodium Hydroxide (UNII: 55X04QC32I)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-013-16	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 17030-013-08	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 17030-013-10	3790 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/17/2017

Labeler - Vetoquinol USA, Inc. (106824209)

Establishment
Name	Address	ID/FEI	Business Operations
American Pharmaceuticals and Cosmetics, Inc.		038023805	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
N.S.Chemicals		650469732	API MANUFACTURE