CLOTRIMAZOLE solution/ drops

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Animal medication manufactured, distributed, or labeled by Vetoquinol USA, Inc., Vetoquinol Products, Amoli Organics Private Limited, Tropichem Research Labs, LLC dba Vetio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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Active Ingredient

Clotrimazole, USP 1%

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Purpose

Antifungal

Uses

For dermatological conditions responsive to Clotrimazole.

Warnings

For external use only. Not for internal use.

When using this product

• Avoid contact with eyes or mucous membranes. If contact occurs, immediately flush with water.

Stop use and consult your veterinarian if

• Skin irritation occurs.

SAFE HANDLING WARNING

Keep out of reach of children.

Directions

Clean and dry affected area. Apply a thin layer morning and evening or as directed by veterinarian. If satisfactory results are not obtained within 2 weeks, consult your veterinarian.

Other information

• Store at controlled room temperature (15-30° C)
• See bottom for Lot No. and Expiration Date.

Inactive Ingredients

Propylene Glycol, SD Alcohol 40B, Chloroxylenol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Benzoyl Alcohol, Citric Acid (pH adjustment), Sodium Hydroxide (pH adjustment).

QUESTIONS?

Manufactured for:
Vetoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
www.vetoquinolusa.com
1 (800) 267-5707

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411417 7

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC: 17030-002-01

Clotrimazole Solution

1% CLOTRIMAZOLE

DROPS FOR
DOGS & CATS

Net Contents: 1 fl oz (30 mL)

vetoquinoL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution/ drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17030-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PHOSPHATE ION (UNII: NK08V8K8HR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	YELLOW (Clear to Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-002-01	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/03/2018

Labeler - Vetoquinol USA, Inc. (106824209)

Registrant - Vetoquinol Products (106824209)

Establishment
Name	Address	ID/FEI	Business Operations
Amoli Organics Private Limited		862234820	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Tropichem Research Labs, LLC dba Vetio		603123068	ANALYSIS, LABEL, MANUFACTURE, PACK