Label: PRAMOXINE ANTI ITCH- pramoxine hydrochloride shampoo

  • NDC Code(s): 62570-101-01, 62570-101-12
  • Packager: Davis Manufacturing and Packaging Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 6, 2019

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  • DESCRIPTION

    Davis Pramoxine Anti-ItchTM Shampoo helps to provide rapid, temporary relief from pruritis caused by a variety of dermatologic conditions. The safe, fast acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent to aid in alleviating itching and discomfort. Colloidal Oatmeal and moisture-rich emollients condition the skin and help prevent future dryness and flaking while Omega-6 fatty acids provide dermal nourishing. Davis Pramoxine Anti-Itch Shampoo is gentle enough for frequent use and leaves the coat with a healthy shine and pleasant scent.

  • SPL UNCLASSIFIED SECTION

    Environment Friendly

    MADE IN THE USA

    Davis Manufacturing

    541 Proctor Avenue

    Atlanta/Scottdale, GA 30079

    www.davismfg.com

    800-292-2424

  • ACTIVE INGREDIENT

    Active Ingredients: Pramoxine Hydrochloride 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Ceterimenium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, Colloidal Oatmeal, Triethenolamine, Herbal Fragrance, FD&C Yellow #5, Chocolate Dye

  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR USE

    Wet coat thoroughly with warm water.  Apply shampoo to head ears, then lather.  Do not get shampoo into eyes or nose.  Repeat procedure with neck, chest, middle and hindquarters, finishing with legs.  Allow shampoo to be absorbed for 5 to 10 minutes then rinse thoroughly.  May be used as often as necessary or as directed by a veterinarian.  For optimal results, use in conjunction with Davis Pramoxine Anti-Itch TM Creme Rinse.  For added benefit between baths, apply Pramoxine Anti-Itch TM Spray to localized areas.

  • PRECAUTIONS

    If contact with eyes or nose occurs, rinse thoroughly.  If irritation or redness persist or increases, discontinue use and consult a veterinarian.

  • KEEP OUT OF REACH OF CHILDREN

    For External Use Only

    Keep Out of Reach of Children

  • PRINCIPAL DISPLAY PANEL

    Davis Veterinary Products
    Pramoxine Anti-Itch TM Shampoo
    With 1% Pramoxine Hydrochloride
    For Dogs, Cats, Puppies and Kittens
    Anti-pruritic formula alleviates scratching and flaking associated with seborrhea dermatitis and other skin disorders

    12 Fl. Oz. (355 ml)

    PSH12

    Davis

    Veterinary Products

    Pramoxine

    Anti-Itch TM

    Shampoo

    With 1% Pramoxine Hydrochloride

    For Dogs, Cats, Puppies and Kittens

    Anti-pruritic formula alleviates

    scratching and flaking associated with

    seborrhea dermititis and other skin disorders

    1 Gallon (3.785 Liters)

    PSHG

  • INGREDIENTS AND APPEARANCE
    PRAMOXINE ANTI ITCH 
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62570-101-12355 g in 1 BOTTLE
    2NDC:62570-101-013785 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/14/2017
    Labeler - Davis Manufacturing and Packaging Inc (106680523)
    Registrant - Vanessa Solis (106680523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davis Manufacturing and Packaging Inc106680523api manufacture
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