Label: DAVIS PRAMOXINE ANTI-ITCH- pramoxine lotion/shampoo

  • NDC Code(s): 62570-100-01, 62570-100-12
  • Packager: Davis Manufacturing and Packaging 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 April 27, 2018

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  • DESCRIPTION

    Davis Pramoxine Anti-ItchTM Creme Rinse helps to provide rapid, temporary relief from pruitis caused by a variety of dermatologic conditions while renourishing the skin and leaving the coat more manageable.  The safe, fast-acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent that aids in alleviating itching and discomfort.  Colloidal Oatmeal and moisture-rich emollients condition and nourish the skin and help prevent future dryness and flaking.

  • SPL UNCLASSIFIED SECTION

    Made in the USA

    Manufactured by:

    Davis Manufacturing 

    541 Proctor Avenue

    Scottdale, GA 30079

    www.davismfg.com

  • ACTIVE INGREDIENT

    Active Ingredient: Pramoxine Hydrochloride 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Cetrimonium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, FD&C Yellow #5, Chocolate Dye

  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR USE

    After shampooing and thoroughly rinsing, aplly creme rinse over the entire coat.  Rub in Well.  Do not get into eyes or nose.  Allow creme rinse to be absorbed for 5 to 10 minutes before lightly rinsing.  For residual results, do not rinse and use as a leave on conditioner.  May be used as often as necessary or as directed by a veterinarian.

  • PRECAUTIONS

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

    For External Use Only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach

    of Children and Pets

  • Gallon display panel

    Davis Veterinary Products

    Pramoxine

    Anti-ItchTM

    Creme Rinse

    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)

    Gallon

  • 355 ml size

    Davis Veterinary Products

    Pramoxine

    Anti-ItchTM

    Creme Rinse

    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.

    12 Fl. Oz. (355 ml)

    355 ml

  • INGREDIENTS AND APPEARANCE
    DAVIS PRAMOXINE ANTI-ITCH 
    pramoxine lotion/shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 45:10:45; 1200000 MW) (UNII: F11YNO8FDQ)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    oatmeal (UNII: 8PI54V663Y)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62570-100-12355 g in 1 BOTTLE
    2NDC:62570-100-013785 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/03/2018
    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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