DERMAZOLE MEDICATED  FOR DOGS, CATS, AND HORSES- miconazole nitrate and salicylic acid shampoo 
Virbac AH, 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.

----------

Dermazole™
MEDICATED SHAMPOO

DERMAZOLE™ Medicated Shampoo is an antiseptic shampoo designed for use on dogs, cats and horses with dermatological conditions responsive to miconazole.

■ USES

DERMAZOLE Medicated Shampoo is a gentle, antiseptic shampoo indicated for the temporary relief of scaling due to dandruff (seborrhea).

■ ACTIVE INGREDIENTS

Miconazole 2% w/w and Salicylic Acid 2% w/w.

■ CONTAINS

Water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, triethanolamine, hydrogenated talloweth-60 myristyl glycol, DMDM hydantoin, polyquaternium-7, fragrance, FD&C yellow #5. May also contain sodium chloride and/or sodium hydroxide.

■ DIRECTIONS FOR USE

Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create rich lather. Massage DERMAZOLE Medicated Shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water.

Frequency of use: Initially two to three times a week for four weeks, then reducing to once a week, or as directed by your veterinarian.

■ WARNING

Keep out of reach of children. Wash hands after use.

■ CAUTION

Federal law (USA) restricts this drug to use by or on order of a licensed veterinarian.

For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

AVAILABLE THROUGH LICENSED VETERINARIANS ONLY

LOT NO. AND EXP. DATE ON BOTTOM

ALLERDERM®

P.O. Box 162059
Fort Worth, Texas 76161
1-800-338-3659

250237-02

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 51311-010-16

Virbac
ANIMAL HEALTH

DERMATOLOGY

Dermazole™

MEDICATED SHAMPOO
FOR DOGS, CATS
AND HORSES

MICONAZOLE 2% w/w
SALICYLIC ACID 2% w/w

ANTISEPTIC
KERATOLYTIC
CLEANSING

16 fl. oz. (473 mL)

Principal Display Panel - 473 mL Bottle Label
DERMAZOLE MEDICATED   FOR DOGS, CATS, AND HORSES
miconazole nitrate and salicylic acid shampoo
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:51311-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE21 mg  in 1 mL
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID21 mg  in 1 mL
Product Characteristics
ColorYELLOW (CLEAR TO HAZY LIGHT YELLOW TO AMBER VISCOUS LIQUID) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51311-010-16473 mL in 1 BOTTLE
2NDC:51311-010-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/19/1997
Labeler - Virbac AH, Inc. (131568396)

Revised: 12/2013
 
Virbac AH, Inc.