Label: DERMAL-SOOTHE- pramoxine hydrochloride cream

  • NDC Code(s): 17030-042-08, 17030-042-16
  • Packager: Vetoquinol USA, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated October 2, 2018

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  • SPL UNCLASSIFIED SECTION

    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.

  • 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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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
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