DERMAL-SOOTHE- pramoxine hydrochloride shampoo

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 luxurious conditioning shampoo for relieving itching and dry skin. Excellent for use on animals with normal, dry or sensitive skin.

DESCRIPTION:

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

DIRECTIONS:

Remove foil seal prior to use. Shake well. Wet coat thoroughly before applying shampoo. Work into coat until a mild lather is produced. Allow to stand for 10-15 minutes and rinse thoroughly. As with any medicated topical product, gloves should be worn when applying this product.

ACTIVE INGREDIENTS:

Pramoxine Hydrochloride 1%

INACTIVE INGREDIENTS:

USP Purified Water, Decyl Polyglucose, Cocamidopropyl Hydroxysultaine, NM7, Cocamidopropyl Betaine, Ammonium Laureth Sulfate, Cetyl Alcohol, PEG 75 Lanolin, Hydrolyzed Keratin, Colloidal Oatmeal, Glycol Stearate, Citric Acid, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone and Skin Respiratory Factor.

CAUTIONS:

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

KEEP OUT OF REACH OF CHILDREN.
FOR ANIMAL USE ONLY.

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

422629
5

Lot

Exp. Date

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 17030-040-16

vetoquinoL

MICRO PEARLS®
ADVANTAGE

MICRO PEARLS® ADVANTAGE

DERMAL-SOOTHE™
SHAMPOO

Anti-Itch

1% Pramoxine Hydrochloride.
Excellent for use on animals with normal, dry, itchy
or sensitive skin relief.

NORMAL
DRY/ITCHY
DRY/FLAKY

NET CONTENTS: 16 fl oz (473mL)

INGREDIENTS AND APPEARANCE

DERMAL-SOOTHE 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17030-040
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)
Octhilinone (UNII: 4LFS24GD0V)
Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
Decyl Glucoside (UNII: Z17H97EA6Y)
Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Glycol Stearate (UNII: 0324G66D0E)
Cetyl Alcohol (UNII: 936JST6JCN)
Oatmeal (UNII: 8PI54V663Y)
PEG-75 Lanolin (UNII: 09179OX7TB)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-040-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 17030-040-16	474 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