Label: DERMAL-SOOTHE- pramoxine hydrochloride shampoo

  • NDC Code(s): 17030-040-08, 17030-040-16
  • Packager: Vetoquinol USA, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 13, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!