DERMAL-SOOTHE- pramoxine hydrochloride shampoo 
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:

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)

Principal Display Panel - 473 mL Bottle Label
DERMAL-SOOTHE 
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-040
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)  
Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)  
Cetyl Alcohol (UNII: 936JST6JCN)  
PEG-75 Lanolin (UNII: 09179OX7TB)  
Oatmeal (UNII: 8PI54V663Y)  
Glycol Stearate (UNII: 0324G66D0E)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17030-040-08237 mL in 1 BOTTLE, PLASTIC
2NDC:17030-040-16474 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
Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Tropichem Research Labs, LLC dba Vetio603123068MANUFACTURE

Revised: 12/2021
Document Id: c0303f80-54dd-4a14-99aa-b410348c91e6
Set id: b3fdf6a1-2ba2-45a4-b1f4-9241886ba025
Version: 5
Effective Time: 20211213
 
Vetoquinol USA, Inc.