Label: DAVIS MELALEUCA- melaleuca shampoo

  • NDC Code(s): 62570-061-01, 62570-061-12
  • 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 November 7, 2019

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  • DESCRIPTION

    Davis Melaleuca Shampoo helps provide soothing relief for pets suffering from dry, itchy and irritated skin. It is formulated with a synergistic combination of natural oils, penetrants and emollients featuring the soothing action of Melaleuca Alternifolia Oil. This natural ingredient, derived from the Australian Tea Tree, provides rapid action and deep skin penetration to help revive the pet's coat and skin.  The addition of Vitamin E, Wheat Germ Oil, Rosemary, and Coconut Oil assists in nourishing the skin and rebuilding a healthy coat. Davis Melaleuca Shampoo is effective, yet mild and may even be used for routine shampooing.

  • SPL UNCLASSIFIED SECTION

    Environment Friendly

    MADE IN THE USA

    Davis Manufacturing

    541 Proctor Avenue

    Atlanta/Scottdale, GA 30079

    www.davismfg.com

  • DIRECTIONS FOR USE

    Wet Coat thoroughly with warm water. Apply shampoo to head and ears, then lather. Do not get shampoo into eyes. Repeat procedure with neck, chest, middle and hindquarter, finish with legs. Rinse thoroughly.

  • WARNINGS AND PRECAUTIONS

    Some pets have unusually sensitive skin. Discontinue use if irritation develops.

  • DOSAGE FORMS & STRENGTHS

    DILUTION RATES                                                        PARTS WATER                                               PARTS SHAMPOO 
     GENERAL USE 5                        1                 
     MILD CONDITIONS 3 1
     SEVER CONDITIONS 1 1

  • INACTIVE INGREDIENT

    INGREDIENTS: AMMONIUM LAURYL SULFATE, TEA TREE OIL, COCOMIDOPROPYL BETAINE, COCONUT BASED LATHERING AGENT, PROPYLENE GLYCOL, COSMETIC GRADE PRESERVATIVE, GREEN DYE, pH ADJUSTER, PURIFIED WATER

  • KEEP OUT OF REACH OF CHILDREN

    FOR EXTERNAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN 

  • PRINCIPAL DISPLAY FOR 355 ML

    DAVIS VETERINARY PRODUCTS

    MELALEUCA SHAMPOO

    WITH VITAMIN E AND ROSEMARY

    FOR DOGS, CATS, PUPPIES AND KITTENS

    FOR CONDITIONS ASSOCIATED WITH SEBORREA DERMITIS, BACTERIA AND FUNGI

    12 FL. OZ. (355 ML)

    62570-061-12

  • PRINCIPAL DISPLAY PANEL

    DAVIS VETERINARY PRODUCTS

    MELALEUCA SHAMPOO

    WITH VITAMIN E AND ROSEMARY

    FOR DOGS, CATS, PUPPIES AND KITTENS

    FOR CONDITIONS ASSOCIATED WITH SEBORREA DERMITIS, BACTERIA AND FUNGI

    1 GALLON (3.785 LITERS)

    62570-061-01

  • INGREDIENTS AND APPEARANCE
    DAVIS MELALEUCA 
    melaleuca shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.7239 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62570-061-12355 g in 1 BOTTLE
    2NDC:62570-061-013785 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2018
    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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