SEBOZOLE  DEEP CLEANING, ANTIMICROBIAL- miconazole nitrate, salicylic acid, and chloroxylenol shampoo 
Vetoquinol USA, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sebozole™ Shampoo
Deep Cleaning, Antimicrobial

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

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

INACTIVE INGREDIENTS: Purified Water, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, PEG 150 Pentaerythrityl Tetrastearate, Lauramide DEA, Sodium Thiosulfate, Sodium Hydroxide, Acrylates/C10-30 Alkylate Crosspolymer, Fragrance, FD&C Blue #1, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow #5.

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

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.

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.

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)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
SEBOZOLE   DEEP CLEANING, ANTIMICROBIAL
miconazole nitrate, salicylic acid, and chloroxylenol shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
PEG-150 Pentaerythrityl Tetrastearate (UNII: 8L4OOQ76AM)  
Lauric Diethanolamide (UNII: I29I2VHG38)  
SODIUM THIOSULFATE ANHYDROUS (UNII: L0IYT1O31N)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Thiosulfate (UNII: HX1032V43M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17030-013-16473 mL in 1 BOTTLE, PLASTIC
2NDC:17030-013-08237 mL in 1 BOTTLE, PLASTIC
3NDC:17030-013-103790 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/08/2020
Labeler - Vetoquinol USA, Inc. (106824209)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Hanpu Pharmaceutical CO. LTD654030428API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Hebei Jingy Medical Technology545119575API MANUFACTURE

Revised: 12/2020
Document Id: 0e2dc5a7-ef6e-416e-9c30-ab120f505552
Set id: da35bd57-2298-4993-b54d-5952a13ac102
Version: 3
Effective Time: 20201210
 
Vetoquinol USA, Inc.