Label: DERMAL-SOOTHE- pramoxine hydrochloride spray

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 5, 2018

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  • SPL UNCLASSIFIED SECTION

    Patented Continuous Moisture Release

  • INDICATIONS:

    A soothing, anti-itch, moisturizing spray for application after shampooing or between shampoos as needed. Aids in the relief of itching and flaking due to dry skin. May be used with other medicated shampoos as directed by your veterinarian.

  • DESCRIPTION:

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

  • DIRECTIONS:

    Shake well. Spray liberally onto damp or dry coat, allowing spray to reach the skin. Repeat as necessary.

  • ACTIVE INGREDIENTS:

    Pramoxine Hydrochloride 1%

  • INACTIVE INGREDIENTS:

    USP Purified Water, NM3, Lactamide MEA, Fragrance, Quaternium 15, Citric Acid.

  • CAUTIONS:

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

  • WARNINGS

    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

    411528
    8

    Lot

    Exp. Date

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    NDC 17030-041-12

    vetoquinoL

    MICRO PEARLS®
    ADVANTAGE

    MICRO PEARLS® ADVANTAGE

    DERMAL-SOOTHE™
    SPRAY

    Anti-Itch Moisturizing Spray

    1% Pramoxine Hydrochloride.
    For Itchy, Dry Skin Relief.

    DRY/ITCHY
    DRY/FLAKY

    NET CONTENTS: 12 oz (355mL)

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DERMAL-SOOTHE 
    pramoxine hydrochloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-041
    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)  
    N-Lactoyl Ethanolamine (UNII: 900T44YNC7)  
    Quaternium-15 (UNII: E40U03LEM0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17030-041-12355 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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