DERMAL-SOOTHE- pramoxine hydrochloride spray

Dermal-Soothe by

Drug Labeling and Warnings

Dermal-Soothe by is a Animal medication manufactured, distributed, or labeled by Vetoquinol USA, Inc., American Pharmaceuticals and Cosmetics, Inc., Syn-Tech Chem. & Pharm. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Patented Continuous Moisture Release

INDICATIONS:

A soothing, anti-itch, moisturizing spray for application after shampooing or between shampoos as needed. Aids in the relief of itching and flaking due to dry skin. May be used with other medicated shampoos as directed by your veterinarian.

DESCRIPTION:

Micro Pearls® Advantage Dermal-Soothe™ Anti-Itch Spray is a remarkable breakthrough in animal care technology. Dermal-Soothe™ Anti-Itch Spray contains itch-relieving Pramoxine Hydrochloride and Novasome® microvesicles designed to deliver long-lasting moisture factors to the hair and epidermal layers in a humidifying spray containing Lactamide MEA. The result is an itch relieving spray that leaves your pet with a coat that is soft, supple and lustrous.

DIRECTIONS:

Shake well. Spray liberally onto damp or dry coat, allowing spray to reach the skin. Repeat as necessary.

ACTIVE INGREDIENTS:

Pramoxine Hydrochloride 1%

INACTIVE INGREDIENTS:

USP Purified Water, NM3, Lactamide MEA, Fragrance, Quaternium 15, Citric Acid.

CAUTIONS:

For topical use only on dogs and cats. Avoid contact with eyes and mucous membranes. Discontinue use if skin becomes irritated or inflamed.

WARNINGS

AVAILABLE ONLY THROUGH LICENSED VETERINARIANS. KEEP OUT OF REACH OF CHILDREN. FOR ANIMAL USE ONLY.

SPL UNCLASSIFIED SECTION

Novasome® is a registered trademark of Micro Pak, Inc.

QUESTIONS?

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

411528
8

Lot

Exp. Date

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

NDC: 17030-041-12

vetoquinoL

MICRO PEARLS®
ADVANTAGE

MICRO PEARLS® ADVANTAGE

DERMAL-SOOTHE™
SPRAY

Anti-Itch Moisturizing Spray

1% Pramoxine Hydrochloride.
For Itchy, Dry Skin Relief.

DRY/ITCHY
DRY/FLAKY

NET CONTENTS: 12 oz (355mL)

INGREDIENTS AND APPEARANCE

DERMAL-SOOTHE 
pramoxine hydrochloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17030-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
N-Lactoyl Ethanolamine (UNII: 900T44YNC7)
Quaternium-15 (UNII: E40U03LEM0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-041-12	355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/29/1999

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
Syn-Tech Chem. & Pharm. Co., Ltd.		656002532	API MANUFACTURE