UNIVERSAL MEDICATED- chloroxylenol, salicylic acid, and sodium thiosulfate shampoo

UNIVERSAL MEDICATED by

Drug Labeling and Warnings

UNIVERSAL MEDICATED by is a Animal medication manufactured, distributed, or labeled by Vetoquinol USA, Inc., Hebei Jingye Medical Technology Corp.,LTD., Tropichem Research Labs, LLC dba Vetio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Universal Medicated Shampoo may be used as adjunctive therapy for the most common dermatological conditions.

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS:

Chloroxylenol 2%, Salicylic Acid 2%, Sodium Thiosulfate 2% (source of soluble sulfur).

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS:

USP Purified Water, Sodium Olefin Sulfonate, Propylene Glycol, Cocamidopropyl Betaine, Polyquaternium-10, Sodium Hydroxide, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid and FD&C Blue #1.

DOSAGE & ADMINISTRATION

DIRECTIONS:

Shake well. With tepid water, thoroughly wet animal's coat. Massage small amounts of shampoo into the coat while continuously adding water to get better dispersion. Continue until a generous lather is generated. Rinse well and repeat procedure. Shampoo may be used weekly or as often as recommended by your veterinarian.

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CAUTIONS:

Keep out of the reach of children. For topical use only. Avoid contact with eyes. If eye contact occurs, immediately flush with water.

STORAGE AND HANDLING

STORAGE:

Store at controlled room temperature.

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QUESTIONS?

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 17030-016-16

vetoquinoL

UNIVERSAL
MEDICATED
SHAMPOO

Deep Cleansing, Antimicrobial

2% Chloroxylenol, 2% Salicylic Acid, 2% Sodium Thiosulfate.
Antimicrobial, Antifungal and Deodorizing.

YEAST/
BACTERIA
ANTIFUNGAL
DRY/FLAKY
OILY/FLAKY

NET CONTENTS: 16 fl oz (473mL)

INGREDIENTS AND APPEARANCE

UNIVERSAL MEDICATED 
chloroxylenol, salicylic acid, and sodium thiosulfate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17030-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	20 mg  in 1 mL
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL
Sodium Thiosulfate (UNII: HX1032V43M) (Thiosulfate Ion - UNII:LLT6XV39PY)	Sodium Thiosulfate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Propylene Glycol (UNII: 6DC9Q167V3)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Polyquaternium-10 (125 MPA.S at 2%) (UNII: L45WU8S981)
Sodium Hydroxide (UNII: 55X04QC32I)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-016-16	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 17030-016-10	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