DERMAL-SOOTHE- pramoxine hydrochloride cream 
Vetoquinol USA, 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.

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Dermal-Soothe™

Patented Continuous
Moisture Release

INDICATIONS:

An itch relieving, moisturizing cream rinse for application after shampooing. May be used on normal, dry or sensitive skin to provide itch relief, lasting moisture and coat luster. May be used with other medicated shampoos as directed by your veterinarian.

DESCRIPTION:

Micro Pearls® Advantage Dermal-Soothe™ Anti-Itch Cream Rinse is a remarkable breakthrough in animal care technology. Dermal-Soothe™ Anti-Itch Cream Rinse contains itch-relieving Pramoxine Hydrochloride and Novasome® microvesicles designed to deliver long lasting moisture factors to the hair and epidermal layers in a rich cream rinse base that relieves itching, dry skin and leaves the hair coat soft, supple and lustrous.

DIRECTIONS:

Remove foil seal prior to use. Shake well. Apply a liberal amount after shampooing. Work into coat and let stand for 10-15 minutes and then rinse thoroughly. As with any medicated topical product, gloves should be worn when applying this product.

ACTIVE INGREDIENTS:

Pramoxine Hydrochloride 1%

INACTIVE INGREDIENTS:

Cetyl Alcohol, Citric Acid Monohydrate, Collagen, Dimethicone, Fragrance, Glycol Stearate, Myristalkonium Chloride, NM3, Oatmeal, PEG-100 Stearate, Quaternium 15, Skin Respiratory Factor, Sodium Stearoamphoacetate, Water

PRECAUTIONS:

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

AVAILABLE ONLY THROUGH LICENSED VETERINARIANS. 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

422628
4

Lot

Exp. Date

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 17030-042-16

vetoquinoL

MICRO PEARLS®
ADVANTAGE

MICRO PEARLS® ADVANTAGE

DERMAL-SOOTHE™
CREAM RINSE

Anti-Itch

1% Pramoxine Hydrochloride.

Long lasting moisturizer for normal, dry, itchy or
sensitive skin relief.

NORMAL
DRY/ITCHY
DRY/FLAKY

NET CONTENTS: 16 fl oz (473mL)

Principal Display Panel - 237 mL Bottle Label
DERMAL-SOOTHE 
pramoxine hydrochloride cream
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Oatmeal (UNII: 8PI54V663Y)  
Dimethicone (UNII: 92RU3N3Y1O)  
Pork Collagen (UNII: I8442U2G7J)  
PEG-100 Stearate (UNII: YD01N1999R)  
Glycol Stearate (UNII: 0324G66D0E)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Sodium Stearoamphoacetate (UNII: I9MO470Z8J)  
Myristalkonium Chloride (UNII: 0W255OL75T)  
Quaternium-15 (UNII: E40U03LEM0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17030-042-08237 mL in 1 BOTTLE, PLASTIC
2NDC:17030-042-16474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/29/1999
Labeler - Vetoquinol USA, Inc. (106824209)
Establishment
NameAddressID/FEIBusiness Operations
American Pharmaceuticals and Cosmetics, Inc.038023805MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE

Revised: 10/2018
Document Id: 7621eb13-49a8-4cb8-b23d-4806d04d78e7
Set id: d96eee97-5f74-44ac-afcf-b6b0483c982c
Version: 3
Effective Time: 20181002
 
Vetoquinol USA, Inc.